The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit that covers the requirements of several jurisdictions instead of undergoing several audits. This program satisfies all pertinent regulatory parties for medical device companies and encompasses a standardized, global approach to auditing with a focus on reducing the regulatory burden faced by the medical device industry.
A manufacturer is expected to comply only with the requirements related to those jurisdictions where it markets its products.
Let PRP provide the guidance you need on what to expect. Our subject matter experts can help you navigate these changes by sharing how other medical device companies are approaching these challenges.
Since 2012, Professional Resource Partners (PRP) has been honored to serve as a trusted source of quality and regulatory compliance consultants to the medical device and diagnostics industries. In 2017, we launched PRP Quality which specializes in Automotive Quality inspection, sorting, and containment. As an ISO:9001 Certified Business and a WBENC Certified Woman-Owned Business, our company is proud to deliver exceptional professional integrity and service to the many clients we support with our customized approach. It’s also the reason why, when PRP is involved, client expectations are not simply met, but they are consistently surpassed.