MDSAP News and Insights | Oriel STAT A MATRIX

Health Canada Realizes That MDSAP Audit Deadlines Are a Burden for Manufacturers. Here’s How They Are Helping.

Oriel STAT A MATRIX
0
on Apr 16, 2018

The Medical Device Single Audit Program (MDSAP) implementation date seemed light years away when it was first announced in late 2013. But with a January 1, 2019 deadline looming, officials at Health Canada are hearing that many manufacturers simply won’t be ready in time or, even worse, have decided that the cost and hassle of […]

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

MDSAP’s Process-Based Audit Approach & Sequence

Oriel STAT A MATRIX
0
on Jul 21, 2017

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 […]

Oriel STAT A MATRIX
0
on Nov 30, 2016

What Is MDSAP’ The Medical Device Single Audit Program ΓÇô or MDSAP ΓÇô allows a single regulatory audit of a medical device manufacturerΓÇÖs quality management system to satisfy the requirements of multiple regulatory authorities (RAs). Five RAs: Australian Therapeutic Goods Administration (TGA), BrazilΓÇÖs Ag├¬ncia Nacional de Vigil├óncia Sanit├íria (ANVISA), Health Canada, MHLW/PMDA (Japan), and the […]

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Category: MDSAP

Health Canada Realizes That MDSAP Audit Deadlines Are a Burden for Manufacturers. Here’s How They Are Helping.

MDSAP’s Process-Based Audit Approach & Sequence

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

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