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Understanding the Benefits and Purpose of MDSAP

The Medical Device Single Audit Program (MDSAP) was developed in 2012 with the goal of creating a system where a single audit could be trusted across multiple jurisdictions.

The programme covers certification for ISO 13485 and other areas. It provides many benefits to manufacturers, including saving time and money. MDSAP audits are becoming increasingly more popular and widely used globally.

This paper provides an overview of MDSAP and what manufacturers can expect from the programme.

What is MDSAP?

MDSAP is a global approach to auditing and monitoring the manufacturing of medical devices and in vitro diagnostics (IVDs) in order to improve their safety and oversight on an international scale.

The programme is intended to allow MDSAP recognised Auditing Organizations to conduct a single regulatory audit of a medical device or IVD manufacturer that will satisfy the relevant regulatory requirements of the five medical device Regulatory Authorities (RA) participating in the programme.

To find out more, download the paper.

Understanding the Benefits and Purpose of MDSAP

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