Medical Device Single AuditProgram (MDSAP)Quality management systems complying withinternational medical device regulations

What else we can do for you

Certifications and accreditations on the basis of

n ISO 13485 Process-oriented, industry-specific standard based on ISO 9001 with further require-ments concerning safety and traceability. Relevant for: Manufacturers, distributors and service providersin the medical devices sector.

n ISO 9001 Standard applied and recognized world-wide to ensure the quality of processes and results in order to improve the competitive factor. Relevant for: Every enterprise. The standard enjoys a high level of recognition in healthcare and related social systems.

n Medical Device Directive 93/42/EEC of the Euro-pean Council: Prerequisite for placing medical devices on the market in the European Union. Relevant for: Manufacturers of higher than class I medical devices.

n ISO 15378 is based on ISO 9001 and additionally comprises all GMP (Good Manufacturing Practices) requirements relevant for primary packaging mate-rials. Relevant for: Manufacturers of primary packa-ging materials for drugs and manufacturers with a special focus on hygiene.

Further certifications and registrations in close cooperation with the DQS Group

n i.a. ISO 14001, ISO 50001, BS OHSAS 18001, SCC/SCP; AZAV

Pre-submission meeting

Training, seminars, workshops

DQS-MED ERFA-Club medical devices

Process audits

Contact us

or visit our homepage.

About us

DQS Medizinprodukte GmbH

n Independent and competent management partner for companies of all sizes and in all industries.

n In 1995, established as the DQS center of excellence for medical devices and designated as a notified body for directive 93/42/EEC.

n Founded in 2008 as a wholly owned subsidiary of DQS Holding GmbH.

n Currently supervising more than 1600 customers with 200 auditors and experts.

n Operating in the areas of medical device approvals and certification of management system in the health care markets for more than 25 years.

DQS Group

n More than 80 offices in over 60 countries,

n Approx. 25,000 customers currently representing approximately 75,000 certified sites in over 130 countries in almost all industries

n Worldwide, approximately 2,800 employees, includingabout 2,300 auditors and experts

n Today it counts to one of the world's largest certificationbodies

n Other German subsidiaries of DQS Holding GmbH, headquartered in Frankfurt am Main

¨ DQS GmbH

¨ DQS CFS GmbH

DQS Medizinprodukte GmbH

August-Schanz-Straße 21D 60433 Frankfurt am MainPhone +49 69 95427-300Fax +49 69 95427-388info@dqs-med.dewww.dqs-med.de Rev.: 03

Office Tuttlingen

Königstraße 13D 78532 TuttlingenTel. +49 7461 1617460

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MDSAP – for whom?

The Medical Device Single Audit Program (MDSAP) is aprogram that allows the conduct of a single regulatoryaudit of a medical device manufacturer’s quality ma-nagement system that satisfies the requirements ofmultiple regulatory jurisdictions.

Your benefits, a single Audit will:

n minimize disruptions for medical device manufac-turer due to the increasing number of regulatoryaudits and inspections

n incorporate ISO 13485 audit requirements, in-cluding regulatory requirements of participatingjurisdictions (Australia, Brazil, Canada, Japan, USA)

n provide predictable audit schedules and outcomes

n educe expenses in time and resource dealing with findings from multiple audits

n benefit patient health and patient access with ease of entry to multiple international markets

n improve transparency in the industry

The MDSAP Certification ProcedurePrinciples and Significanc

The MDSAP is a way that medical device manufacturerscan be audited once for compliance with the standard andregulatory requirements of up to five different medicaldevice markets: Australia, Brazil, Canada, Japan and theUnited States. The program’s main mission is to “…jointlyleverage regulatory resources to manage an efficient,effective, and sustainable single audit program focusedon the oversight of medical device manufacturers.”

MDSAP should be considered for companies based globally, if they wish to sell products into the countries participating:

n The Australian Therapeutics Goods Administration (TGA) will use an MDSAP audit report as part of the evidence that is assessed for compliance withmedical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements.

n The Brazilian National Health Surveillance Agency (ANVISA) will utilize the outcomes of the program,including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures.

n Health Canada (HC) will exclusively accept MDSAP audit outcomes as part of their Canadian MedicalDevice Conformity Assessment System (CMDCAS) certification program for class II, III and IV medicaldevice licenses, to prove regulatory compliance with quality management system requirements in Canada.

n U.S. Food and Drug Administration’s Center forDevices and Radiological Health (FDA) will accept the MDSAP audit reports as a substitute for FDA routine inspections. Additionally, certification documentsstating compliance with applicable US regulations may provide a marketing advantage.

n The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both premarket and periodical post market audits under regulations in Japan.

PROCEDURAL CYCLEtakes 3 years

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