The Medical Device Single Audit Program (MDSAP) enables medical device manufacturers to undergo a single audit accepted by MDSAP member countries.
As an Auditing Organization (AO), our MDSAP services help you comply with the quality management system (QMS) regulatory requirements for the medical device regulatory authorities of Australia, Brazil, Canada, the US and Japan.
We help you to:
Participating in MDSAP enables you to:
We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for sustainability, quality and integrity. As an AO, we can conduct a single audit that will be accepted by the regulatory authorities of the following jurisdictions and their regulatory requirements:
The audit also covers other specific requirements of medical device regulatory authorities participating in the MDSAP program, including registration, licensing, technical documentation review and adverse event reporting.
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program and the European Union (EU) are Official Observers of MDSAP.
Contact us to discover the benefits of MDSAP.
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
