Category: MDSAP

Ready, Set, Score! Understanding the MDSAP Grading System

In this game, a high score is not the goal! The MDSAP grading system (GHTF/SG3/N19:2012 – Nonconformity Grading System) was established to address inconsistencies from traditional audit grading approaches like “major finding,” “minor finding,” and “opportunity for improvement” by establishing objective criteria to characterize the significance of findings that can be easily shared among participating Regulatory Authorities (RAs). How It Works During an MDSAP Audit, nonconformities are assigned a grade/score of 1 to 5 that is calculated using a two-step […]

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All Topics, MDSAP

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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All Topics, Auditing, MDSAP

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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All Topics, MDSAP
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