Gap Assessment Tool to help you be ready for an MDSAP Audit.
This document contains all the questions an Auditing Organization can ask you to get MDSAP Certified.
This tool is divided on many tabs:
Measurment, Analyze and Improvement
Advertisment and Advisory Reporting
Design and Development
Production and Service controls
I also included a table with all the regulations that are mentioned.
What else can we do so you are MDSAP certified?
This tool can help you to do the Gap Assessment yourself, but maybe you still need a confirmation that what you have performed is correct before your Certification Audit?
- Easy Medical Device is proposing you to perform a Mock Inspection and test your system. This will then give you more confidence before the audit.
- We can also train your team on how an Audit is executed and how to be prepared (before, during and after).
- In the case you need more, please contact us at firstname.lastname@example.org