MDSAP enables medical device manufacturers to undergo a single audit that is accepted by MDSAP member countries. As an Auditing Organization (AO), our MDSAP services help you to comply with the quality management system (QMS) regulatory requirements for the medical device regulatory authorities of Australia, Brazil, Canada, the United States 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 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.
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