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Preparing for the Medical Device Single Audit Program (MDSAP)

A Practical Introduction & Guide to Certification Success

The Medical Device Single Audit Program (MDSAP) is a global initiative designed to harmonize regulatory efforts around the world. But despite looming deadlines, comparatively few medical device companies have a meaningful understanding of the advantages (and disadvantages) of pursuing MDSAP certification and how to prepare accordingly.

We've compiled insights from experts who have firsthand experience helping device manufacturers prepare for the MDSAP and compiled them into this handy white paper.

What you'll find inside:

• The basics of the MDSAP
• How the new grading system works
• Which kinds of medical device companies stand to benefit from the MDSAP
• What to consider before pursuing MDSAP certification
• How to prepare for success before auditors arrive

Whether you’re a VP, Director, Regulatory Affairs Manager, Quality Assurance Professional, Consultant, or anyone else involved in ensuring regulatory compliance is maintained, you'll come away with actionable takeaways you can use to make an informed decision about the MDSAP and how to prepare for it.

Meet the contributor

Corrine Bonfiglio
Quality System and Regulatory Affairs Consultant

Corrine has over twenty five years of accomplished regulatory, quality assurance, and clinical affairs experience with FDA and ISO regulatory requirements, including quality systems, regulatory submissions, CE marking and clinical trial development. She has assisted medical device manufacturers with regulatory strategies and the submission of IDE’s, 510(k)’s, and PMAs as well as the implementation of compliant quality systems including correcting deficiencies found during FDA, state or notified body inspections, auditing, and training. Corrine specializes in creating and implementing compliant quality systems for 21 CFR 820 and ISO 13485:2003 for medical device companies; full quality system audits; quality system training in both seminar and small group formats; and labeling and promotional material review.