MDSAP Mock Audits – Getting QA and RA on the Same Page

As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the like. As companies grow, the scope of responsibilities narrows and people in QA and RA don’t interact as much as they should. That’s about to change and it’s being driven by one thing: MDSAP. As you may […]

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MDSAP’s Process-Based Audit Approach

Oriel STAT A MATRIX can help answer your questions about the Medical Device Single Audit Program.

Short-Term Pain = Long-Term Gain The MDSAP audit model uses a process-based approach and defines the required audit sequence, nonconformity grading, scoring mechanism, and time requirements per process. In addition, the auditors must examine regulatory requirements from multiple countries. While the MDSAP audit may be more difficult at first, the payoff is big: A single audit satisfies multiple regulatory authorities. MDSAP’s Process-Based Audit Approach MDSAP’s process-based approach is different from the traditional checklist-style audit that reviews documentation and conformance to […]

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The Medical Device Single Audit Program (MDSAP): What You Need to Know

What Is MDSAP? The Medical Device Single Audit Program – or MDSAP – allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities (RAs). Five RAs: Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA) participated in a three year MDSAP Pilot which concluded in December 2016. These RAs will continue to participate in […]

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