MDSAP: Requirements for the United States (FDA)
Thanks to the MDSAP (Medical Device Single Audit Programme), it is possible to access multiple markets with a single audit. This white paper provides an overview of MDSAP requirements with specific reference to the United States.
1.INTRODUCTION
The Medical Device Single Audit Programme (MDSAP) is an audit programme – established by the International Medical Device Regulators Forum (IMDRF) – that enables the assessment of the conformity of a medical device manufacturer’s Quality Management System (QMS) […]
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