MDSAP Program | MDV-Solve
MDSAP Program
The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.
We support you with:
- MDSAP audit preparation
- Mock audits and gap analysis
- QMS integration for multiple jurisdictions (USA, Canada, Brazil, Australia, Japan)
- Addressing audit findings and non-conformities
Related Services
Design Control Under EN ISO 13485 & 21 CFR PART 820
Establish and implement a system for design controls for various classes of medical devices.
+ Learn MoreQuality System under EN ISO 13485, US FDA QSR - GMP
The purpose is to enable you to establish and implement an effective tailored QMS system …
+ Learn MoreThe Literature Route for Clinical Evaluations
Practical solution on evaluation of clinical data for CE marking medical devices and local regulation.
+ Learn More