Overall Preparation for the MDSAP Audit requires:

Embedded Standards

Manufacturers to ensure those standards are fully embedded within their own quality systems, which may involve several methodical methods.

All Participating Countries

Manufacturers to look comprehensively at ALL of the participating countries’ requirements.

Retention Procedures

Documentation of retention procedures addressing the requirements of all participating countries.

ISO 13485:2016

Full incorporation of new changes in regulations, such as ISO 13485: 2016.

Due Diligence

Due diligence via support from senior leadership/management to be fully successful.