introduction...medical and pharmaceutical communities, translating from english and french into...

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Since 1973 Consuetudo certissima est loquendi magistra Introduction Dear Sirs, I would like to introduce myself as a seasoned, academically qualified provider for the medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their writing and translation needs. A lifelong study of both source and target languages, coupled with in-depth knowledge of the pharmaceutical and medical device industries, allow me to offer independently- reviewed, first-class Portuguese translations that faithfully and accurately capture the style and meaning of the original and read as fluently throughout three continents and all Portuguese-speaking markets. My specialisms are: Annexes, Automated systems, Bioengineering, Cardiology, Clinical protocols, Clinical trials, Endoscopy, Expert reports, GI, Immunohaematology, IVD, MA applications, MSDS, Ophthalmology, Orthopaedics, Pharmacodynamics, Pharmacokinetics, Product Information, QRD, Registration documents, Safety, Scientific papers, SPCs, PILs, Labelling, IB, Toxicology, Vascular surgery. Attached please find my résumé for your consideration. Looking forward to hearing from you, I am, Sincerely, Manuel Delgado, Ph.D. Skype bujinin1 [email protected] Dr Manuel Delgado Linguistic Consultancy—Medical & Pharma Translation R. Conrado Cabral 384, Ap 804 60325-440 Fortaleza, CE—Brazil Tel.: +5585-3035-8170

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Page 1: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Since 1973

Consuetudo certissima est loquendi magistra

Introduction

Dear Sirs, I would like to introduce myself as a seasoned, academically qualified provider for the medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their writing and translation needs. A lifelong study of both source and target languages, coupled with in-depth knowledge of the pharmaceutical and medical device industries, allow me to offer independently-reviewed, first-class Portuguese translations that faithfully and accurately capture the style and meaning of the original and read as fluently throughout three continents and all Portuguese-speaking markets. My specialisms are: Annexes, Automated systems, Bioengineering, Cardiology, Clinical protocols, Clinical trials, Endoscopy, Expert reports, GI, Immunohaematology, IVD, MA applications, MSDS, Ophthalmology, Orthopaedics, Pharmacodynamics, Pharmacokinetics, Product Information, QRD, Registration documents, Safety, Scientific papers, SPCs, PILs, Labelling, IB, Toxicology, Vascular surgery. Attached please find my résumé for your consideration. Looking forward to hearing from you, I am, Sincerely,

Manuel Delgado, Ph.D.

Skype bujinin1 [email protected]

Dr Manuel Delgado Linguistic Consultancy—Medical & Pharma Translation R. Conrado Cabral 384, Ap 804

60325-440 Fortaleza, CE—Brazil Tel.: +5585-3035-8170

Page 2: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Skype bujinin1 [email protected]

CCURRICULUMURRICULUM VVITAEITAE

Academic background

Doctor Psychological Sciences Master African Religions

Languages

ENGLISH FRENCH PORTUGUESE

Eight years of formal studies Since 1973 in translation business

Seven years of formal studies Since 1973 in translation business

Mother tongue

Expertise

REGULATORY MEDICAL DEVICES CLINICAL TRIALS

Annexes

Expert reports

MA applications

Product Information

QRD

Registration documents

SPCs, PILs, Labelling, IB

Automated systems

Bioengineering

Cardiology

Dentistry

Endoscopy

GI

Immunohaematology

IVD

MSDS

Ophthalmology

Vascular surgery

Clinical protocols

Expert reports

Pharmacodynamics

Pharmacokinetics

Safety

Scientific papers

Toxicology

Equipment

HARDWARE SOFTWARE

AMD FX 6-Core Black Edition

Internet cable connection

Windows 7 Ultimate

Office 2007 Professional

SDL Trados Studio 2017

MultiTerm 2017

Consuetudo certissima est loquendi magistra

Since 1973

Page 3: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Regulatory translation

Seretide Accuhaler/Diskus™, salmeterol/fluticasone propionate, SPC Artenam (β-Artmether), package leaflet Desogestrel 75 mg film-coated tablets, package leaflet CO-2 Endoscopic Insuflator Tubing set, package leaflet MSDSs, IFUs, Labelling, Packaging, CIS ATG-Fresenius 20 mg/ml concentrate for solution for infusion, SPC ATG-Fresenius 20 mg/ml concentrate for solution for infusion, PL Medroxyprogesterone Acetate, CDS Sayana® Medroxyprogesterone Acetate, Suspension for injection, PL Numerical Rating Scales for Diabetic Peripheral Neuropathy Hospital Anxiety and Depression Scale (HADS) Neuropathy Total Symptoms Score (NTSS-6) M.D. Anderson Symptom Inventory – Head & Neck (MDASI-HN) SQOR-V Forcaltonin, SPC Lovastatin, Clinical Expert Report Lovastatin 20 mg and 40 mg tablets, Expert Reports on the Chemical and Pharmaceutical Documentation Holetar® (Lovastatin), Expert Report on Pharmaco-Toxicological (Preclinical) Documen-tation Fluoxetine 20/498.2C, Hard Gelatin Capsules, Expert Report on the Pharmacological and Toxicological Part Fluoxetine, Expert Report on the Clinical Documentation Fluoxetine CF 20, tablets, Product Profile Fluoxetine Stada® 20 mg tablets, Proposal for packaging, labelling and Package insert Fluoxetine Stada® 20 mg tablets, SPC Cetirizine Dihydrochloride mg/ml oral solution, Expert Report on the Chemical and Phar-maceutical Documentation Vasilip® (simvastatin), Expert Report on the Pharmaco-toxicological Preclinical Docu-mentation Simvastatin film-coated tablets, Clinical Expert Report Simvastatin 5, 10, 20 and 40 mg film-coated tablets, Expert Report on the Chemical and Pharmaceutical Documentation Fluconazole 50, 100, 150 and 200 mg capsules, Expert Report on the Pharmacological-toxicological Documentation Sildenon 25, 50 and 100 mg film-coated tablets, Package Leaflet Sildenon 25, 50 and 100 mg film-coated tablets, Summary of Product Characteristics Etanercept, Clinical Overview Geodon®, Package Leaflet Epelin®, Package Leaflet 13-Valent Pneumococcal Conjugate Vaccine, General Information 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), Qualification Summary Report Atorvastatin Calcium, Large, Oval, Film-Coated Tablets, Post-Approval Stability Protocol

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Skype bujinin1 [email protected]

Baxter

Dr August Wollf

Fresenius

GSK

King Pharma

Medac

Pfizer

Stada

Synthon

Unigene

Arenco Pharma

Sandoz

Biotech

Bracco Diagnost

Page 4: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Regulatory translation (cont.)

Fluconazole 50, 100, 150 and 200 mg capsules, Expert Report on the Clinical Documenta-tion Fluconazole 50, 100, 150 and 200 mg capsules, Pharmacotechnological Expert Report Felodipine 2.5 mg/5 mg/10 mg CR-TABS film-coated tablets, Pharmacotechnological Ex-pert Report Felodipine controlled release 2.5, 5 and 10 mg Siegfried, Pharmacological-toxicological Expertise Felodipine Extended Release Formulations, Expert Report on the Clinical Documentation Felodipine 2.5 mg/5 mg/10 mg CR-TABS, Pharmaceutical Expert Report Loratadine Liquid 5 mg/5 ml, Pharmacotoxicological Expert Report Loratadine tablets 10 mg, Clinical Expert Report Loratadine Liquid 5 mg/5 ml, Clinical Expert Report Loratadine tablets 10 mg, Pharmacotoxicological Expert Report Centralized ECG procedure manual for Pfizer AO221047 Loratadine tablets 10 mg, Pharmaceutical Expert Report Alprazolam 0.25, 0.5, 1 and 2 mg tablets, Clinical Expert Report Alprazolam 0.25, 0.5, 1and 2 mg tablets, Pharmacological and Toxicological Expert Report Trancon 0.25 mg tablets, Expert Report on Chemical/Parmaceutical Documentation Tisseel, Tissucol and Duo Stm4, SPC Alprazolam tablets, SPC Cetiristad 10 mg, film-coated tablets, PL Clonmentin Tablets 500/125mg, Proposal for Packaging, Labelling and Package Insert Hidroxyurea medac, Patient Information Leaflet, SPC Roxithromycin, Expert report on the pharmacological-toxicological documentation Roxithromycin, Expert report on the clinical documentation Psorimed, SPC, PL Quality Assurance Standards & Procedures for Methylparaben NF, Propylparaben NF, So-dium Citrate USP Hydrous (Granular), Citric Acid USP Hydrous (Granular), Trimethoben-zamide Hydrochloride USP, Water for injection, Nitrogen NF, Sodium Hydroxide NF (Pellets), Sodium Hydroxide 10% Solution Quality Assurance Laboratory Stability Report Cardiostad, SPC Fluvoxamine maleate tablets, PL Omeprazole 20, Omeprazole 40, Expert Report on the Pharmacological-Toxicological Documentation Omeprazole 20, Omeprazole 40, Expert Report on the Clinical Documentation Omeprazole 20 mg, capsules, Pharmaceutical Expert Report Lisinopril, Expert reports on the chemical and pharmaceutical documentation Lisinopril, Expert report on the clinical documentation Lisinopril, Expert report on the pharmacological-toxicological documentation

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

Skype bujinin1 [email protected]

Biotech

Dr August Wollf

Fresenius

GSK

King Pharma

Medac

Pfizer

Stada

Synthon

Unigene

Baxter

Sandoz

Bracco Diagnost

Arenco Pharma

Page 5: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Regulatory translation (cont.)

PD-0332991, Investigator’s Brochure Lumigan 1.0 mg/ml, Summary of Product Characteristics Fluvoxamine maleate tablets, Clinical Expert Report Fluvoxamine maleate tablets, Pharmaceutical Expert Report Fluvoxamine maleate tablets, Pharmaco-Toxicological Expert Report Psorimed, Reproduction Toxicity, Mutagenic Potential, Pharmacodynamics, Pharmacoki-netics, Local Tolerance Studies Psorimed, Expert Reports on the Clinical Documentation Psorimed, Pharmaceutical Expert Report Psorimed, AMA Psorimed, AMA of a Medical Product in a Member State of the European Union Psorimed, Approval of Product Licence Psorimed, SPC Psorimed, Container Labelling Psorimed, Manufacturing Licence Omeprazole, enteric-coated tablets, Pharmaceutical Expert Report Omeprazole, enteric-coated tablets, Expert Report on the Clinical Documentation Omeprazole, enteric-coated tablets, Expert Report on the Pharmacological-Toxicological Documentation Pomaglumetad methionil, Investigator’s Brochure Bazedoxifene Acetate, Validation of Analytical Procedures Bazedoxifene Acetate, Analytical Procedures Bazedoxifene Acetate, Specification Bazedoxifene Acetate, Impurities Bazedoxifene Acetate, Elucidation of Structure and other Characteristics Bazedoxifene Acetate, Description of Manufacturing Process and Process Controls Bazedoxifene Acetate, General Properties Bazedoxifene Acetate, Structure Bazedoxifene Acetate, Nomenclature WAY-160546, Chemical and Pharmaceutical Development CP-690,550 Protocol LTE_adhoc, Treatment Emergent Adverse Events and Exposure-Adjusted Event Rates by SOC, HLGT and PT Celecoxib Pfizer 100/200 mg capsules, hard, SPC Celecoxib Pfizer 100/200 mg hard capsules, Package leaflet Kudeq 100/200 mg capsules, hard, SPC Kudeq 100/200 mg hard capsules, Package leaflet Celebra 100/200 mg hard capsules, Package leaflet Celebra 100/200 mg capsules, hard, SPC

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Skype bujinin1 [email protected]

Baxter

Dr August Wollf

Fresenius

GSK

King Pharma

Medac

Pfizer

Stada

Synthon

Unigene

Arenco Pharma

Sandoz

Biotech

Bracco Diagnost

Allergan Pharma

Page 6: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

Edwards Lifesciences Aquarius™ System Platinum Software V. 6.02 Edwards Lifesciences Aquarius™ Automated Fluid Balance Monitor BOND™ Fully Automated IHC and ISH Staining System Sysmex pocH-100i Automated Hematology Analyzer Sysmex UF1000i Fully Automated Urine Particle Analyzer Sysmex XS-1000i/XS800i Automated Hematology Analyzer XS Series Sysmex UF-100i Fully Automated Urine Cell Analyzer UF-100 Series Sysmex XE IPF master Upgrade Software for Automated Hematology Analyzer Sysmex SP-1000i Automated Hematology Slide Preparation Unit Sysmex XT-2000i / XT-1800i Automated Hematology Analyzer Sysmex pocH-100i Automated Hematology Analyzer LIAISON® Control Anti-TPO LIAISON® Anti-Tg Integra 400 in vitro diagnostic reagent system Integra 700 in vitro diagnostic reagent system COBAS Integra system Bond™ hybridization staining system COBAS b 101 system, Operator’s Manual and QRG

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Byk-Sangtec

Edwards Lifesciences

Leica BioSystems

Roche

Sysmex

Vision BioSystems

Skype bujinin1 [email protected]

Page 7: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

Talent Occluder, IFU, Endovascular therapies ActivaRC Implant Manual, Deep brain stimulation Confida Sheath, Catheter therapies ThoraTrack MICS Retractor, Cardiovascular surgical therapies Amphirion Deep, Endovascular therapies OctoBase Retractor Tack, Cardiovascular surgical therapies GEnius Power Cord, Cardiac rhythm disease management ablation therapies Pacific Xtreme, Endovascular therapies Intercept patient manual, Deep brain stimulation Arrive Sheath, Cardiac rhythm disease management ablation therapies Achieve catheter cable, Cardiac rhythm disease management ablation therapies Achieve manual, Cardiac rhythm disease management ablation therapies Adapta PPG, Core therapies NC Euphora OUS, IFU, Coronary therapies DBS Patient Therapy Guide, Deep brain stimulation Affinity Art Fil, Cardiovascular surgical therapies MRI Guidelines InterStim, Gastroenterology and Urology Arctic Front CA Catheter, Cardiac rhythm disease management ablation therapies PatConnect Technical Manual, Cardiac rhythm disease management monitoring Reliant Stent Graft, Endovascular therapies Enlite Sensor Performance, Diabetes core therapies InTRAkit Access Kit, Coronary therapies Symplity G3 User Manual, Coronary therapies VISIA AF Reference Manual SureScan, Cardiac rhythm disease management core therapies VISIA AF MRI, Cardiac rhythm disease management core therapies Symplicity G3 IFU, Coronary therapies LINQ Online Help, Cardiac rhythm disease management monitoring Verify 3531 User Manual, Gastroenterology and Urology Quick- Serter, Diabetes core therapies 640G Startup Guide, Diabetes core therapies Tango SW Patient, Gastroenterology and Urology Tango SW Clinician, Gastroenterology and Urology Tango SW Shared, Gastroenterology and Urology MiniLink Transmitter, Diabetes core therapies Percutaneous Lead, Cardiac rhythm disease management core therapies Novus 5054 Lead Manual, Cardiac rhythm disease management core therapies VirtualExpress Online Help, Cardiac rhythm disease management monitoring Resolute Onyx, Coronary therapies Adapta PDP, Cardiac rhythm disease management core therapies Endurant Evo, Endovascular therapies

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 8: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

Endurant, endovascular therapies NayaMed, cardiac rhythm disease management core therapies LINQ, cardiac rhythm disease management core therapies Blackwell, cardiac rhythm disease management core therapies Deep brain stimulation for dystonia Deep brain stimulation for move disorder LINQ, cardiac rhythm disease management monitoring LINQ, cardiac rhythm disease management Help InPact Admiral, endovascular therapies Corevalve Evolut, cardiovascular catheter therapies Ascenda drug infusion catheter CardioInsight, cardiac rhythm disease management ablation therapies Tango software, gastroenterology and urology MiniLink, diabetes core therapies CRTD MRI, cardiac rhythm disease management core therapies Percutaneous lead, cardiac rhythm disease management core therapies Novus 5054 Lead Manual, cardiac rhythm disease management core therapies 3T MRI, cardiac rhythm disease management core therapies VirtualExpress, cardiac rhythm disease management, monitoring Achieve ST, cardiac rhythm disease management, ablation therapies Resolute Onyx, coronary therapies Enlite UG, diabetes core therapies Adapta PDP, cardiac rhythm disease management core therapies InterStim® Lead, Gastroenterology and Urology Activa® SC Multi-program neurostimulator, deep brain stimulation Reclaim® DBS™ Therapy, Lead Kit implant manual, deep brain stimulation MiniMed™ 640G Startup Guide, diabetes core therapies Endurant EVO, endovascular therapies NayaMed, cardiac rhythm disease management core therapies Blackwell, cardiac rhythm disease management core therapies 3550-P4, deep brain stimulation LINQ Online Help, cardiac rhythm disease management, monitoring Technical literature, deep brain stimulation for epilepsy InPact Admiral, endovascular therapies CoreValve Evolut, cardiovascular catheter therapies 8780 Ascenda Catheter, Neuro, drug infusion DBS Clinician Android App, Software strings, deep brain stimulation DxTerity EZ-Pak inTRAkit, coronary therapies Viva CRTP ANATEL, cardiac rhythm disease management core therapies Resolute Onyx, coronary therapies

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 9: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

Spark Mobile App, diabetes core therapies Vitatron eIFU, cardiac rhythm disease management core therapies Avalus Valve, cardiovascular catheter therapies VisiaIII manuals, cardiac rhythm disease management core therapies Avalus sizers, cardiovascular catheter therapies Avalus Bioprosthesis, cardiovascular catheter therapies Quick-Serter, diabetes core therapies Cyroconsole EMC, cardiac rhythm disease management ablation therapies Single Chamber EPG, cardiac rhythm disease management core therapies ADVISA DR MRI™ SURESCAN™, cardiac rhythm disease management core therapies Thoracic Stent Graft System, IFU, endovascular therapies Valiant Navion™ Thoracic Stent Graft System, IFU, endovascular therapies InterStim® Lead, Gastroenterology and Urology MiniMed™ 640G, System User Guide, diabetes core therapies AdmiralXtreme PTA Balloon Catheter, IFU, cardiovascular catheter therapies CARELINK ENCORE™, cardiac rhythm disease management TrailBlazer™ Angled Support Catheter, endovascular therapies Annuloplasty Handle model 7686, cardiovascular surgical therapies Mirro MRI™, Digital single chamber implantable cardioverter defibrillator with SureScan™ Technology, cardiac rhythm disease management core therapies Sprint Quattro™, Steroid eluting, quadripolar, ventricular lead, cardiac rhythm disease management core therapies Intercept™ Model 37441 Patient Programmer User Manual, gastroenterology_and_urology autoLog IQ™ Autotransfusion System, cardiovascular surgical therapies TrailBlazer™ Support Catheter, endovascular therapies CARELINK® 2290 Analyzer, cardiac rhythm disease management core therapies SynchroMed® and IsoMed® implantable infusion systems, drug infusion Intellis Neurostimulation System, spinal cord stimulation Intellis PTM, spinal cord stimulation TYRX™Absorbable Antibacterial Envelope, cardiac rhythm disease management core therapies  SynchroMed® Implantable infusion system, technical literature IsoMed® Implantable infusion system, technical literature Bio-Medicus™ Adult Cannula Kit, cardiovascular surgical therapies MiniMed™ Quick-serter™ User Guide, diabetes core therapies Bio-Medicus™Adult Cannula and Introducer, cardiovascular surgical therapies Tri-Ad™ 2.0 Adams Tricuspid Band Sizer Set, cardiovascular surgical therapies Contour 3D™ Sizer Set, cardiovascular surgical therapies  Tri-Ad™ 2.0 Adams Tricuspid Band, cardiovascular surgical therapies

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 10: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

CoreValve™ Evolut™ R System, cardiovascular catheter therapies Abre™ Venous Self-expanding Stent System, endovascular therapies CIT200 CardioInsight™ Cardiac Mapping System, cardiac rhythm disease management, ablation therapies EAZ101 Sternal tunneling tool, cardiac rhythm disease management core therapies 5392 Dual Chamber Temporary External Pacemaker, cardiac rhythm disease management core therapies Percepta™ MR Conditional pacemaker with cardiac resynchronization therapy, cardiac rhythm disease management core therapies Attesta™ Dual chamber rate responsive pacemaker, cardiac rhythm disease management core therapies SPRINT QUATTRO SECURE MRI™ SURESCAN™,MR Conditional, steroid-eluting, quadripolar, screw-in, ventricular lead with RV/SVC defibrillation coil electrodes, cardiac rhythm disease management core therapies Avalus™ Bioprosthesis, IFU, cardiovascular surgical therapies Guardian™ Connect, User Guide, diabetes core therapies VenaSeal™ Closure System, IFU, endovascular therapies Evolut™ PRO+ System, IFU, cardiovascular catheter therapies Shockwave S4, Peripheral Intravascular Lithotripsy Catheter Envision™ Pro CGM System, IFU, diabetes core therapies Pacific™ Plus PTA Catheter, IFU, cardiovascular catheter therapies One-Press Serter, User Guide, diabetes core therapies CoreValve™ Evolut™ PRO Transcatheter Aortic Valve, Delivery Catheter System, IFU, cardiovascular catheter therapies In.Pact™ Falcon™ Paclitaxel-eluting PTCA Balloon Cataheter, cardiovascular coronary therapies X Pain Therapy, Neurostimulation for Chronic Pain, Information for subscribers, peripheral nerve stimulation MiniMed™ 770G, Startup Guide, diabetes core therapies Medical Procedure and EMI Warnings for implanted pacemakers and defibrillators, manual for healthcare professionals, cardiac rhythm disease management core therapies Riptide™ Aspiration Pump, User’s Manual, neurovascular core therapies Neurostimulation systems for pain, Reference Manual, spinal cord stimulation CareLink iPro Software, User Guide, diabetes core therapies Cardioblate™ Surgical Ablation Pen, IFU, cardiovascular surgical therapies Solitaire™ Detachment System, IFU, neurovascular core therapies Restore™ Clinician Programmer Application, Programming Guide, spinal cord stimulation Affinity™ Centrifugal Blood Pump, IFU, cardiovascular surgical therapies MVP™ Micro Vascular Plug System, IFU, endovascular therapies Dextile™ Anatomical Mesh, IFU

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 11: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

Affinity Pixie™ Oxygenation System with Cortiva™ BioActive Surface, IFU, cardiovascular surgical therapies EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System, IFU, cardiovascular endovascular therapies MVP™ Micro Vascular Plug System, IFU, cardiovascular endovascular therapies IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter, IFU, cardiovascular endovascular therapies Heli-FX™ EndoAnchor Systems™, IFU, cardiovascular endovascular therapies Aurora EV-ICD™ MRI SureScan™ Cardioversion Defibrillation Systems, MRI Technical Manual, cardiac rhythm disease management core therapies Bio-Medicus Life Support, Catheter and Introducer, Extracorporeal Membrane Oxygenation and Extracorporeal Life Support, IFU, cardiovascular surgical therapies Cardioblate™ CryoFlex™ Surgical Ablation Console, Operator’s Manual, cardiovascular surgical therapies Reveal™ XT Insertable Cardiac Monitor, Patient manual, cardiac rhythm disease management, monitoring Affinity Pixie™ Arterial Filter, IFU, cardiovascular surgical therapies Talent™ Endoluminal Occluder System, IFU, cardiovascular endovascular therapies Verify® External Neurostimulator for InterStim® Therapy, User manual, gastroenterology and urology SimuForm™ Semi-Rigid Annuloplasty Ring, IFU, cardiovascular surgical therapies Affinity™ Arterial Filter with Cortiva™ Bioactive Surface, IFU, cardiovascular surgical therapies Activa™ SC, Multi-program neurostimulator, implant manual, deep brain stimulation Epsila EV™ Sternal Tunneling Tool, technical manual, cardiac rhythm disease management core therapies Activa™ RC Multiprogram Rechargeable Neurostimulator, Implant Manual, deep brain stimulation StimLoc™ Burr Hole Cover, technical manual, deep brain stimulation Minimed™ Mio™ Advance, Infusion Set, IFU, diabetes core therapies Affinity NT™ 511B, 541B Oxigenator with Balance™ Biosurface and Cardiotomy/Venous Reservoir, IFU, cardiovascular surgical therapies Aurora EV-ICD™ MRI SureScan™ DVEA3E4, reference manual, cardiac rhythm disease management core therapies Reliant™ Stent Graft Balloon Catheter, IFU, endovascular therapies Guardian™ Connect User Guide, diabetes core therapies

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 12: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

SynchroMed™ and IsoMed™ Implantable Infusion Systems, indications, drug stability and emergency procedures, deep brain stimulation OctoBase™ Suture Holding Inserts, IFU, cardiovascular surgical therapies Affinity™ Adapter, IFU, cardiovascular surgical therapies SimuPlus™ Polysulfone and Silicone Sizers, IFU, cardiovascular catheter therapies MRI Guidelines for InterStim™ systems, gastroenterology and urology MyCareLink Relay™ Home Communicator, Patient’s Manual, cardiac rhythm disease management, monitoring Getting Started with MiniMed™ 670G Continuous Glucose Monitoring, diabetes core therapies Contour 3D™Annuloplasty Ring, cardiovascular surgical therapies AMPLIA MRI™ QUAD CRT-D implantable cardioverter defibrillator, cardiac rhythm disease m core therapies Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, cardiovascular coronary therapies ATTAIN™Deflectable catheter delivery system technical manual, cardiac rhythm disease management core therapies Intercept™ Model 37441 Patient Programmer, deep brain stimulation for epilepsy LINQ II™ Insertable Cardiac Monitor, cardiac rhythm disease management core therapies Open Pivot™ Heart Valve, cardiovascular surgical therapies Affinity NT™ Oxygenator with Biosurface and Cardiotomy/Venous Reservoir, cardiovascular surgical therapies SpiderFX™ Embolic Protection Device, cardiovascular therapies Spyral Catheter, IFU, coronary therapies SynchroMed™ Infusion System, Clinician Programming Guide, drug infusion Bio-Medicus Life Support™, Catheter and Introducer, Extracorporeal Membrane Oxygenation and Extracorporeal Life Support, IFU, cardiovascular surgical therapies Clinician App for Sacral Modulation Therapy, Clinician Programming Guide for the Verify™ Evaluation System, gastroenterology and urology Atakr™ Plus, RF Ablation Generator, Operator’s Manual, cardiac rhythm disease management ablation therapies CareLink SmartSync™, Technical Manual, cardiac rhythm disease management, monitoring Pipeline™ Vantage Embolization Device with Shield Technology™, IFU, neurovascular core therapies Tri-Ad™ 2.0 Adams Tricuspid Band Sizer Set, IFU, cardiovascular surgical therapies Phenom™ Catheter, IFU, neurovascular core therapies MiniMed™ 780G System User Guide, diabetes core therapies Affinity™ Arterial Filter, IFU, cardiovascular surgical therapies autoLog IQ™, Autotransfusion System, Quick Setup Guide, cardiovascular surgical therapies 

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 13: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Cardiology

Flex-Tip Transluminal A-Pacing Probe Swan-Ganz Flow-directed Monitoring Catheters PreSep Central Venous Oxymetry Catheter Intro-Flex Tuohy-Borst Valve Introducer 3M™ Littmann® Electronic Stethoscope Q-Stress® v3.5, Exercise Test Monitor Quick Guide to Cardiopulmonary Care Atria 6100 Electrocardiograph Vari-Lase Laser Console ATS SIMULUS™ FLX-O Annuloplasty Ring ATS SIMULUS™ FLX-C Annuloplasty Band Xience™ Everolimus Eluting Coronary Stent System VARI-LASE Flex™ endovenous laser procedure kit SKYWAY™ OTW Support Catheter TWIN-PASS™ Dual Access Catheter ATS Open Pivot® Heart Valve Sizer Set ATS Medical Thoracic Port System LANGSTON™ Dual Lumen Pigtail Catheter Trio™ Portable Bedside Vital Signs Monitor Panorama™ ISM Telemetry Specifications Sheet Panorama™ Central Station Specifications Sheet Datascope’s Trio Monitor Merci™ Thrombus & Foreign Body Retriever Jometrics SmartWire1 Pressure Guide Wire Percutaneous Thrombectomy Catheter with Integral Motor Drive unit GalileoTM centering catheter GalileoTM III centering catheter WarmTouch® CareDrape™ Cardiac Blanket

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

3M

ATS Medical

Bacchus Vascular

Cardiac Science

Datascope

Edwards Lifesciences

Guidant

Jomed

Nellcor Puritan

Quinton Cardiology

Vascular Solutions

Skype bujinin1 [email protected]

Page 14: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Automated Systems

CoreValve™ Evolut™ R System, cardiovascular catheter therapies Abre™ Venous Self-expanding Stent System, endovascular therapies CIT200 CardioInsight™ Cardiac Mapping System, cardiac rhythm disease management, ablation therapies EAZ101 Sternal tunneling tool, cardiac rhythm disease management core therapies 5392 Dual Chamber Temporary External Pacemaker, cardiac rhythm disease management core therapies Percepta™ MR Conditional pacemaker with cardiac resynchronization therapy, cardiac rhythm disease management core therapies Attesta™ Dual chamber rate responsive pacemaker, cardiac rhythm disease management core therapies 

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

Medtronic

Skype bujinin1 [email protected]

Page 15: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Dentistry

Alginot™ Alginate Alternative Impression Material Take 1® Advanced™ Bite RealSeal 1™ Bonded Obturator System Scotchbond™ Dual Cure Dental Adhesive RelyX™ Ceramic primer RelyX™ Luting cement Silginat® Strawberry impression Dispersalloy® Dispersed Phase Alloy Self-Activating Capsule Megalloy® EZ Spherical Alloy S elf-Activating Capsule Core-X™ Flow Dual Cure Core Build-Up Material and Cement SwissTEC A-Silicone Impression SwissTEC C-Silicone Impression SwissTEC Bond and Etchant SwissTEC Composite

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS

Since 1973

Consuetudo certissima est loquendi magistra

3M ESPE

Coltène

Dentsply DeTrey

Fettenbach

SybronDental

SybronEndo

Skype bujinin1 [email protected]

Page 16: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Endoscopy

Pentax Video GI Scopes Pentax EPK-i HiLINE HD+ Video Processor NaviAid™ Balloon Guided Endoscopy Webster® Deflectable Tip Electrode Catheter Pentax EB-1970UK Ultrasound Video Bronchoscope Pentax EG-290Kp and EC-380MKp Video GI Scopes FI-7BS, FI-9BS, FI-10BS, FI-13BS, FI-16BS Portable intubation scopes Endoscopic Accessories, Retrieval Basket Pentax EPK-i HiLine+ Video Processor EG-2990i, EG-2990K, EC-3890LK Video GI Scopes EC-3890Li/Fi/Mi/Fi2/Mi2 Video GI Scopes Pentax Video Processor EPK-100 Series PRONTO™ Short Extraction Catheter Skyway OTW catheter Pentax Endoscopic Accessories, Grasping Forceps Pentax Endoscopic Accessories, Endoscopic Aspiration/Injection Needles Pentax Endoscopic Accessories, DH series Snares Pentax Endoscopic Accessories, GB series Retrieval Basket Pentax PSV-4000 Medical Video Camera for Endoscopy Pentax FG series Ultrasound Upper GI Fiberscopes Pentax Endoscopic Accessories: DK series Hot Biopsy Forceps Pentax Endoscopic Accessories, KW, KH, KA, KS Series Biopsy Forceps Pentax OS-H2 and OS-H4 Water Bottle Assemblies Pentax SAT-1300 Isolation transformer Pentax FNL Series Video-Naso-Pharyngo-Laryngoscopes Pentax VNL Series Video-Naso-Pharyngo-Laryngoscopes Pentax Ultrasound Upper GI Videoscopes Peripherally Inserted Central Catheter (PICC) Pentax BF Series Portable Bronchoscopes Pentax FI Series Portable Intubation Scopes Pentax FNL-10RBS Portable Naso-Pharyngo-Laryngoscopes Visual Guide for the Placement of the Arrow® Cannon Catheter II™ Pentax 70K and 80K Series GI Scopes

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Arrow

Asahi Optical

ATS Medical

Biosense Webster

Pentax

Rüsch

Smart Medical

Stryker

Vascular Solutions

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Page 17: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical Devices—Endoscopy (cont.)

Pentax Ultrasound Upper GI Videoscopes, Curved Linear Array Type Pentax Ultrasound Upper GI Videoscopes, Radial Array Type Pentax EG Series Video Upper GI Scopes Pentax ED Series Video Duodenoscopes Pentax Video Lower GI Scopes Pentax EPK-1000 Video Processor Pentax LH-150PC Halogen Light Source Pentax 30 Series Video Slim Scopes Pentax 30 Video Bronchoscopes Pentax 30 Video Naso-Pharyngo-Laryngoscopes Pentax 30 Video Choledocho-Nephroscopes Pentax 30 Video Cystoscopes Pentax 30 Video Hysteroscopes Pentax 70K Video Slim Scopes Pentax 70K Video Bronchoscopes Pentax W Series GI Fiberscopes Pentax V Series GI Fiberscopes Pentax FB Bronchofiberscopes Rüsch Tracheal and bronchial, oral and nasal tubes Pentax Ultrasound Upper GI Videoscopes Pentax EB Video Bronchoscopes Pentax Safe-1000 Autofluorescence Endoscopic Imaging System Stryker Navigation System Straight Pedicle Feeler Stryker Navigation System Sterilization Container Stryker Digital Capture Image Pro Pentax K, TK Series Video Duodeno Scopes Pentax 40K Series Video Upper GI Scopes Pentax 40K Series Video Duodeno Scopes OptiVu HDVD™ System Stryker Navigation System, Tibial/Pelvic Tracker Stryker High Speed Bur Attachment Stryker Navigation System, Spine Tracker Suction/Irrigation Front Actuating Electrocautery Probe EPK-700 Video Processor and Video Endoscope Pentax EB Video Bronchoscopes Pentax ED-3490TK Video Duodenoscope Pentax Video Upper GI Scopes, EG Series Pentax EB-1970UK Ultrasound Video Bronchoscope

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

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Arrow

Asahi Optical

ATS Medical

Biosense Webster

Pentax

Rüsch

Smart Medical

Stryker

Vascular Solutions

Skype bujinin1 [email protected]

Page 18: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Immunohaematology

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

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DiaMed

Bio-Rad

MycXtra™ Fungal DNA Extraction Kit for IVD use ID-PaGIA Leishmaniasis antibody test Impact-R Test Kit, platelet functions in anticoagulated whole blood ID-PaGIA Heparin/PF4 antibody test ELISA-Malaria antibody test, Plasmodium spp. Control plasmas for coagulation tests DiaReptin, Bothrops atrox, determination of reptilase time DiaThrombin, Thrombin time determination DiaCelin-L, Liquid Cephaloplastin, PTT and Heparin determination ID-HbS Sickle cell test DiaMed Reference Plasma, PT, PTT, TT, reptilase time, Fibrinogen, Anti-Trombin III DiaCell Dia+, Antibody screening DiaBrom, Liquid stable bromelin DiaLISS-Control, indirect Coombs Anti-I, human, for tube DiaMed test sera for antiglobulin test ID-PaGIA Detection of anti-Treponema pallidum antibodies DiaMed-IT LEISH, Human Visceral Leishmaniasis Factor XIII deficient plasma determination of factor XIII activity Diluent N.A. Anti-Tja, human, for tube test “DiaClon Anti-Jka” and “DiaClon Anti-Jkb”, monoclonal, IgM antibody Anti-D Reference Reagent, monoclonal “ID-Anti-D” for confirmation of Dweak by IAT ID-DiaScreen, Detection of irregular antibodies DiaCidel, acid-elution of serological antibodies Monospecific Coombs Sera Anti-M / Anti-N, Determination of antigen M (MNS1) and N (MNS2) DC-Screening II, IgG, C3d, ctl, DAT Bovine albumin DiaClon Anti-Lea / Leb, monoclonal, IgM antibody “Anti-P1”, goat, determination of the P1 antigen PNH test with the ID-Card “ID-PNH” ID-CellWash-P, Wash solution for papainised red cells DC-Screening I, IgG-IgA-IgM-C3c-C3d-ctl, DAT DiaPlastin, Liquid calcium-thromboplastin, rabbit brain for PT determination DiaLISS, LISS-albumin reagent ID-PaGIA Chagas antibody test, anti-Trypanosoma cruzi DiaClon AB0/D(VI+/VI-) + DAT ID-Card “AB0/Rh for newborns” OptiMAL-IT, individual rapid malaria test OptiMAL Positive control DiaMed-MP, determination of Rh phenotypes and Kell DiaMed-MP, AB0/Rh D blood grouping

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Myconostica

Page 19: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Immunohaematology (cont.)

ID-Card “Heparin/PF4 antibody test”, Particle Gel Immuno Assay ID-DiaPanel Plus 6, screening and identification ID-DiaScreen Prophylax, screening and identification ID-Card “AB0-Rh”, blood groups AB0 and Rh D with human antibodies DiaPanel, test cell panel for antibody identification Coombs-control IgG, antihuman globulin test Coombs serum IgG, anti-humanglobulin serum DiaClon Coombs-serum, polyvalent, direct and indirect antiglobulin test DiaClon Anti-H, monoclonal, IgM antibody, determination of A subgroups ID-Cards “Anti-Kpa” and “Anti-Kpb”, determination of the Kpa and Kpb ID-FMH Screening Test ID-Card “Anti-D”, human, determination of Rh D and weak D Factor deficient plasmas, determination of coagulation factors DiaFibrinogen “O”, liquid Thrombin/Kaolin reagent, bovine DiaMed test sera for antiglobulin test ID-CellStab, glycine buffered saline “ID-Papain”, papain solution Anti-H Lectin, determination of H antigen and H substance in saliva Anti-A1 Lectin, determination of A-subgroup A1 ID-Card “DAT IgG1/IgG3”, determination of IgG subclasses DAT IgG-Dilution, determination of IgG Anti-CDE, human, for tube test Anti-D, human, for tube test, determination of Rh D “DiaCell I+II” and “DiaCell I+II+III”, antibody screening “DiaClon Anti-M” and “DiaClon Anti-N” monoclonal antibodies DiaClon Rh Control, Rh determination ID-Antigen profile I, II and III ID-Card “LISS/Coombs” “ID-Anti-I” and “ID-Anti-I”, determination of I/i antigens ID-Cards “Anti-Lua” / “Anti-Lub”, determination of Lua and Lub ID-Cards “S” and “s”, determination of MNS3 and MNS4 ID-Card Reverse grouping with antibody screening ID-Card “DiaClon Anti-K”, determination of KEL1 ID-Cards “Anti-K” / “Anti-k”, determination of Kell and Cellano ID-Card “DiaClon Anti-H”, determination of A subgroups ID-Card “Anti-CW”, determination of CW ID-Card “AB0-Rh”, blood groups AB0 and Rh D Anti-A, Anti-B, Anti-AB for AB0 blood grouping ID-Card “Complete Crossmatch”, compatibility testing ID-Card “Coombs Anti-IgG”, direct and indirect antiglobulin testing ID-Card “DiaClon Rh-subgroups + K”, determination of Rh phenotypes and Kell ID-Card “Rh D + Phenotype” ID-Partial Rh D-Typing Set

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

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DiaMed

Bio-Rad

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Myconostica

Page 20: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Immunohaematology (cont.)

ID-Card DiaClon Complete Crossmatch, A-B-D(VI-)/Enz./AHG-AHG ID-Card "AB0 /Rh D", A-B-AB-D(VI+) –D(VI-) –ctl ID-Card "DiaClon ABD-Confirmation for Donors” DiaClon Anti-D complete, monoclonal, IgM antibody Rh-Subgroups + K, C-c-E-e-K-ctl human Rh-Subgroups +Cw + K, C-Cw-c-E-e-K human DiaClon Anti-CDE, -C, -E, -c, -e monoclonal IgM antibodies DiaClon Anti-A, DiaClon Anti-B, DiaClon Anti-AB monoclonal ID-Cards "DiaClon Anti-M" and "DiaClon Anti-N" monoclonal ID-Card "Anti-A1 absorbed" human DiaMed test sera for the Rh System, Anti-C, -c, -E, -e, Cw DiaDimer LX-2 Calibration Kit DiaDimer Performance control low and high, latex enhanced turbidometric assays ID-Diluent 2, Modified LISS ID-Diluent 1, Modified bromelin ID-Card "NaCl, enzyme test and cold agglutinins" Rh-Control for test tube ID-Cards "DiaClon Anti-Jka"/DiaClon Anti-Jkb" ID-Card "Fya" /ID-Card "Fyb" ID-Card "LISS/Coombs" ID-Card "DiaClon ABD-Confirmation for patients" ID-Card "DiaClon Anti-DVI neg." ID-Card "DiaClon AB0/Rh for patients" DiaMed-ID Particle Gel Immuno Assay human anti-IgA antibody test DiaMed-ID Particle Gel Immuno Assay Syphilis antibody test DiaCell-MP AB0, reverse grouping on microplates DiaClon-MP, AB0/Rh D blood grouping on microplates Ec-Stabilizing solution for red cell suspensions DiaClon Anti-K, determination of KEL1 ID-Card “AB0/D + reverse grouping” ID-Card “ABD Confirmation” Dia-Clon Anti-D monoclonal ID-Card “DiaClon AB0/Rh for donors” ID-Internal Quality Control

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DiaMed

Myconostica

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Page 21: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Immunohaematology (cont.)

ID-Card DiaClon Complete Crossmatch, A-B-D(VI-)/Enz./AHG-AHG ID-Card "AB0 /Rh D", A-B-AB-D(VI+) –D(VI-) –ctl ID-Card "DiaClon ABD-Confirmation for Donors” DiaClon Anti-D complete, monoclonal, IgM antibody Rh-Subgroups + K, C-c-E-e-K-ctl human Rh-Subgroups +Cw + K, C-Cw-c-E-e-K human DiaClon Anti-CDE, -C, -E, -c, -e monoclonal IgM antibodies DiaClon Anti-A, DiaClon Anti-B, DiaClon Anti-AB monoclonal ID-Cards "DiaClon Anti-M" and "DiaClon Anti-N" monoclonal ID-Card "Anti-A1 absorbed" human DiaMed test sera for the Rh System, Anti-C, -c, -E, -e, Cw DiaDimer LX-2 Calibration Kit DiaDimer Performance control low and high, latex enhanced turbidometric assays ID-Diluent 2, Modified LISS ID-Diluent 1, Modified bromelin ID-Card "NaCl, enzyme test and cold agglutinins" Rh-Control for test tube ID-Cards "DiaClon Anti-Jka"/DiaClon Anti-Jkb" ID-Card "Fya" /ID-Card "Fyb" ID-Card "LISS/Coombs" ID-Card "DiaClon ABD-Confirmation for patients" ID-Card "DiaClon Anti-DVI neg." ID-Card "DiaClon AB0/Rh for patients" DiaMed-ID Particle Gel Immuno Assay human anti-IgA antibody test DiaMed-ID Particle Gel Immuno Assay Syphilis antibody test DiaCell-MP AB0, reverse grouping on microplates DiaClon-MP, AB0/Rh D blood grouping on microplates Ec-Stabilizing solution for red cell suspensions DiaClon Anti-K, determination of KEL1 ID-Card “AB0/D + reverse grouping” ID-Card “ABD Confirmation” Dia-Clon Anti-D monoclonal ID-Card “DiaClon AB0/Rh for donors” ID-Internal Quality Control

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Consuetudo certissima est loquendi magistra

DiaMed

Bio-Rad

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Myconostica

Page 22: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

IVD

BD Leucocount Kit, Enumeration of residual leucocytes MycXtra™ Fungal DNA Extraction Kit BasoTest®, Degranulation of basophilic granulocytes Bond™ Polymer AP Red Detection Bond™ Primary Antibody Estrogen Receptor Anti-Fluorescein Antibody RNA Negative Control Probe RNA Positive Control Probe Identification of Lambda light chain messenger RNA (mRNA) Identification of Kappa light chain messenger RNA (mRNA) CMV Identification of human cytomegalovirus early gene RNA transcript EBER Identification of latent EBV infection Bond™ Primary Antibody Bcl-6 Bond™ Primary Antibody Terminal Deoxynucleotididyl Transferase Bond™ Primary Antibody Cytokeratin 8/18 Bond™ Primary Antibody Cytokeratin 5 Bond™ Primary Antibody CD5 Bond™ Primary Antibody CD23 Dia-Asept, Nettoyant-Désinfectant Bond™ Primary Antibody Tyrosinase Bond™ Primary Antibody Thyroid Transcription Factor-1 Bond™ Primary Antibody Melan A Bond™ Primary Antibody Cytokeratin 5 (XM26) Bond™ Primary Antibody CD10 Methods for producing enhanced antigenic Helicobacter Sp. Neonatal Cord Gas Kit QUICK-QC™ Slides Acid-Fast Stain Controls Blood Parasites Controls Tissue Parasites Intestinal Parasites Gram Stain Controls Mycology Controls KWIK-WC™ Slides EZ-PECTM Microorganisms EZ-FPCTM Microorganisms EZ-CFUTM Microorganisms Microbiology Quality Control Slides LYFO Disk® Microorganisms KWIK-STIK™ Microorganisms KWIK-STIK™ Plus Microorganisms Treponema pallidum IgM, μ-capture EIA EZ-CFUTM One Step Microorganisms Eppower TM Microorganisms

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

3M Healthcare

Antex Biologics

BBI Diagnostics

BD Diagnostics

Beckman Coulter

Chiron

Dako Cytomation

Hamilton Bonaduz

Meddens Diagnostics

Medion Diagnostics

MicroBiologics

Myconostica

Orpegen Pharma

Vision BioSystems

Vital Signs

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Page 23: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

IVD (cont.)

Accurun® 146 CMV IgM Positive Control Accurun® 115 Anti-Treponema Positive Control FITC-conjugated F(ab')2 Specific for Mu-Chains FITC-conjugated F(ab')2 Specific for Alpha-Chains FITC-conjugated F(ab')2 Specific for Gamma-Chains FITC-conjugated Polyclonal Rabbit Anti-Human C1q Complement FITC-conjugated Polyclonal Rabbit Anti-Human IgA, IgG, IgM, Kappa, Lambda FITC-conjugated Polyclonal Rabbit Anti-Human Lambda Light Chains FITC-conjugated Polyclonal Rabbit Anti-Human Kappa Light Chains Monoclonal Mouse Anti-Human CD117 LIAISON® Troponin I LIAISON® Tg LIAISON® T4 LIAISON® Myoglobin LIAISON® Control Tg LIAISON® β2 Microglobulin LIAISON® Multi-Control Tumour Markers LIAISON® Anti-TPO LIAISON® Anti-Tg LIAISON® AFP LIAISON® Ferritin LIAISON® CEA LIAISON® CA 19-9® LIAISON® CA 15-3® LIAISON® CA 125IITM LIAISON® Control Troponin I LIAISON® Control Thyroid Human Immunodeficiency Virus Types 1 and 2, strip immunoblot assay Hepatitis C Virus Encoded Antigen/Peptide LIAISON® T3 LIAISON® LH LIAISON® FSH Anti-Jka (JK1), Anti-Jkb (JK2) Mono-Type® Combi Anti-D Mono-Type® Accurin 1® Multi-Marker Positive Control Ortho Summit Processor Attest™ 1298/1298F Rapid Readout Biological Indicator ThinPrep® Review Scope Navigator Pod GasPak™ Gas Generating Container Systems LIAISON® Control fPSA LIAISON® Cortisol® Accurun® 136 Toxoplasma IgM Positive Control

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

3M Healthcare

Antex Biologics

BBI Diagnostics

BD Diagnostics

Beckman Coulter

Chiron

Dako Cytomation

Hamilton Bonaduz

Meddens Diagnostics

Medion Diagnostics

MicroBiologics

Myconostica

Orpegen Pharma

Vision BioSystems

Vital Signs

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Page 24: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Medical / Surgical Devices

ID-Pipetor FP-4 Micro Typing System VolumeView System Imbibe™ Bone Marrow Aspiration Needle Vitagel™ Surgical Hemostat Extended Applicator Vitagel™ Surgical Hemostat CellPacker® Collection Device Vitagel™ Surgical Hemostat Spray Set TheraSphere® Yttrium-90 Glass Microspheres ComfortTouch™ Forehead Thermometer VICKS SpeedRead™ and ComfortFlex™ Digital Thermometers VICKS SmartTemp™ Digital Thermometer Surgeon® Safety Stitch Cutters Surgeon® Safety Scalpels Arrow® Diatek Cannon Catheter II™ TRACER® III Nerve Locator, Model NL3 ProLong™ Continuous Nerve Block Set ProBloc™ Insulated Regional Nerve Block Needle 4Vent, Helmet for CPAP and PSV use Snuggle Warm SW-4000 Convective Warming Unit Percutaneous Thrombectomy Catheter with Integral Motor Drive Paragon® Drug Delivery System Select-a-Flow™ Variable Rate Controller Hawkeye Registration & Calibration QC Silicone Cushion Mask with Inflated Cuff Caddy and Compact Caddy for Oxylog 1000 and Oxylog 2000 Coapt Endotine™ Forehead Instrument Kit VNUS® Closure Procedure: Quick Reference EHD Dual Handpiece Adaptor Life-Air 1000® Hypothermic Therapy System WarmTouch® CareDrape™ Patient Warming System Essure™ Permanent Birth Control Curon Stretta™ System Sporox® IINI Syntra Dialyser TPSTM U2 EliteTM Attachments TinaTM Haemodialysis system Tracheostomy Retainer Set Spiro Speech Valve, Humidifier and Phonation Valve Biesalski tracheostomy set ITI MonoType Implant InterSource radiotherapeutic sources for interstitial implantation Sterility, Membrane Filtration Cleaning & Sterilization Instructions for Non-Sterile/Reusable Instruments Gel Breast Implants, Product Insert Data Sheet Rumi Arch® II, Koh-Efficient™, Vaginal Fornices Delineator & Colpo-Pneumo Oc-cluder™, IFU

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

Arrow

Bacchus Vascular

Coapt Systems

Conceptus

Curon Medical

Dahlhausen

DiaMed

Dräger Medical

Edwards Lifesciences

General Electric

I-Flow

Institut Straumann

Intl Brachytherapy

JAI Surgicals

KAZ

Level 1

MDS Nordion

Nellcor Puritan

Orthovita

Parkedale Pharma

Portex

Rüsch

Stryker Instruments

Sultan Chemists

US Surgical

VNUS Medical

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Mentor

Page 25: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Ophthalmology

Zyoptix® XP Microkeratome Amadeus™ Microkeratome BD HPMC Hypromellose Solution for anterior segment surgical procedures Harmony Total Dual, phaco-emulsification/fragmentation, vitreo-retinal surgery Harmony Special Peristaltic, phaco-emulsification/fragmentation, vitreo-retinal surgery Technolas® 217 Z100 P Laser APT Link Zyoptix® Personalized Vision Correction System

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Adv Medical Optics

Direct Optical

Technolas

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Page 26: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Studies & Trials

Pfizer’s Gaucher’s Disease Learning System Randomized, multicenter, double-blind, Phase 3 study of PD-0332991 Bazedoxifene acetate, Validation of Analytical Procedures Atorvastatin Calcium, Post-Approval Stability Protocol CATNON intergroup trial, Phase III trial on Concurrent and Adjuvant Temozolomide che-motherapy in non-1p/19q deleted anaplastic glioma Numerical Rating Scales for Diabetic Peripheral Neuropathy, Questionnaire translation, reconciliation, cognitive debriefing Hospital Anxiety and Depression Scale (HADS), Questionnaire translation, cognitive de-briefing, reconciliation Neuropathy Total Symptoms Score (NTSS-6), Symptoms Questionnaire translation, cogni-tive debriefing, reconciliation M.D. Anderson Symptom Inventory – Head & Neck (MDASI-HN) Construction and validation of a patient-reported outcome dedicated to chronic venous disorders: SQOR-V (specific quality of life and outcome response - venous) Randomised Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP) Lovastatin, Clinical Expert Report Lovastatin, Pharmaceutical Expert Report Holetar® (Lovastatin), Expert Report on Pharmaco-Toxicological Documentation Fluoxetine, Expert Report on Pharmaco-Toxicological Documentation Fluoxetine, Clinical Expert Report Cetirizine Dihydrochloride mg/ml oral solution, Expert Report on Chemical and Pharma-ceutical Documentation Vasilip® (simvastatin), Expert Report on the Pharmaco-toxicological Documentation Simvastatin, Clinical Expert Report Simvastatin, Expert Report on Chemical and Pharmaceutical Documentation Fluconazole, Expert Report on Pharmaco-Toxicological Documentation Fluconazole, Clinical Expert Report Fluconazole, Pharmacotechnological Expert Report Felodipine, Pharmacotechnological Expert Report Felodipine Siegfried, Pharmaco-Toxicological Expert Report Felodipine Extended Release, Clinical Expert Report Felodipine, Pharmaceutical Expert Report Loratadine Liquid, Pharmaco-Toxicological Expert Report Loratadine tablets, Clinical Expert Report Loratadine Liquid, Clinical Expert Report Loratadine tablets, Pharmaco-Toxicological Expert Report Loratadine tablets, Pharmaceutical Expert Report

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

ANRS

Dr August Wolff

EORTC

King Pharmaceuticals

Oxford Outcomes

Sankyo Pharma

Smithkline Beecham

Stada Arzneimittel

Synthon

Skype bujinin1 [email protected]

Pfizer

Page 27: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Studies & Trials (cont.)

Quality Assurance Standards & Procedures for: Methylparaben NF Propylparaben NF Sodium Citrate USP Hydrous (Granular) Citric Acid USP Hydrous (Granular) Trimethobenzamide Hydrochloride USP Water for injection Nitrogen NF Sodium Hydroxide NF (Pellets) Sodium Hydroxide 10% Solution Omeprazole, Pharmaco-Toxicological Expert Report Omeprazole, Clinical Expert Report Omeprazole, Pharmaceutical Expert Report Lisinopril, Expert Report on Chemical and Pharmaceutical Documentation Lisinopril, Clinical Expert Report Lisinopril, Pharmaco-Toxicological Expert Report Fluvoxamine maleate tablets, Clinical Expert Report Fluvoxamine maleate tablets, Pharmaceutical Expert Report Fluvoxamine maleate tablets, Pharmaco-Toxicological Expert Report Psorimed, Reproduction Toxicity Studies Psorimed, Mutagenic Potential Studies Psorimed, Pharmacodynamics Studies Psorimed, Pharmacokinetics Studies Psorimed, Local Tolerance Studies Psorimed, Clinical Expert Report Psorimed, Pharmaceutical Expert Report Psorimed, Licence Application Psorimed, Application for a Marketing Authorisation of a Medical Product in a Member State of the European Union Psorimed, Approval of Product Licence Psorimed, Manufacturing Licence Omeprazole enteric-coated tablets, Pharmaceutical Expert Report Omeprazole enteric-coated tablets, Clinical Expert Report Clinical Study Protocol: Essai randomisé de phase III comparant l’efficacité et la tolérance du maintien d’une trithérapie avec antiprotéase par rapport à son changement pour une association de FTC/ddI/efavirenz administrée en une prise unique journalière chez des patients infectés par le VIH-1 et présentant une charge virale indétectable Alprazolam tablets, Clinical Expert Report Alprazolam tablets, Pharmaco-Toxicological Expert Report Trancon tablets, Expert Report on Chemical and Parmaceutical Documentation Roxithromycin, Pharmaco-Toxicological Expert Report Roxithromycin, Clinical Expert Report

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

ANRS

Dr August Wolff

EORTC

King Pharmaceuticals

Oxford Outcomes

Sankyo Pharma

Smithkline Beecham

Stada Arzneimittel

Synthon

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Page 28: Introduction...medical and pharmaceutical communities, translating from English and French into Portuguese and Brazilian Portuguese since 1973, helping companies and CROs with their

Studies & Trials (cont.)

A Phase III Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients with Gaucher Disease, Bioanalytical Re-port Crizotinib, Nonclinical Overview Crizotinib, Treatment of Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC), Clinical Overview Taliglucerase Alfa, Elucidation of Structure and Other Characteristics Crizotinib, Core Data Sheet Bazedoxifene (BZA)/Conjugated Estrogens (CE), ManufactureBazedoxifene (BZA)/Conjugated Estrogens (CE), Pharmaceutical Development Bazedoxifene Acetate, Control of Drug Substance Bazedoxifene/Conjugated Estrogens Tablets, Batch Analyses Bazedoxifene (BZA)/Conjugated Estrogens (CE), Validation of Analytical Procedures Bazedoxifene (BZA)/Conjugated Estrogens (CE), Control of Drug Product 

SSELECTEDELECTED LLISTIST OFOF TTRANSLATIONSRANSLATIONS Since 1973

Consuetudo certissima est loquendi magistra

ANRS

Dr August Wolff

EORTC

King Pharmaceuticals

Oxford Outcomes

Sankyo Pharma

Smithkline Beecham

Stada Arzneimittel

Synthon

Skype bujinin1 [email protected]