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Medical Device Single Audit Program (MDSAP)

What is MDSAP?

MDSAP stands for Medical Device Single Audit Program. MDSAP is a program which allows the management of a single regulatory audit of a medical device manufacturers QMS. This single audit fulfills the requirements of many regulatory authorities.

The audits are performed by Auditing Organizations (AO), which must be authorized by the Regulatory Authorities in order to audit for MDSAP. By having a single audit, a manufacturer can be audited once for compliance with the standard and any regulatory requirements, which includes ISO 13485.

How to prepare for MDSAP

If your organization is getting ready to be audited it is advised to carefully go through any internal audits and look over every aspect of your QMS requirements. You should carefully look at any new requirements, and make sure that if you find any shortcomings within your QMS that these issues are fully addressed.

Are all MDSAP standards met with ISO 13485:2016?

MDSAP requires that audits are conducted by AO. During the audit, these auditing bodies look to see if your company meets regulatory requirements, and although ISO 13485:2016 meets many requirements of MDSAP, it is your responsibility to ensure that your company meets any regulatory requirements as well.

ISO 13485 All in One Package