The Pilot version of MDSAP started on January 2014 and was converted through a transitional period lasting until the launch on January 2017 of a fully Operational MDSAP program. The program has it stands is built around a standardized audit and assessment models approach to ensure harmonization of practices amongst Auditing Organizations (AOs) such as LNE/GMED, and meet the expectations of medical device manufacturers looking to leverage the use of their regulatory resources in a unique audit. The Medical Device Single Audit Program (MDSAP) is a regulatory program unique in its ability to facilitate access to the USA, Canada, Brazil, Japan and Australia; offering thus the possibility for companies to be assessed in the course of one single Quality Management System ( QMS) audit for up to 5 regulations at once, a program highly suitable for those selling or planning on selling medical devices into these 5 international jurisdictions.
Stepping into the program when carrying already other regulatory certifications requires from medical device companies to understand not only the approach but the expectations set by the applicable regulations and the concept carried on by the program: from the MDSAP auditing scope to the MDSAP grading system for non-conformities and the duration of the MDSAP audit , everything within the MDSAP format is thought to ensure consistency in introducing a harmonized approach meant to provide a global benefit both on short term goals and longer term goals by IMDRF regulators and benefit patient health and patient access.
Join Dharmendra Thakur, Certification Project Manager and Design Dossier Evaluator at GMED North America, Inc. and learn about the MDSAP concept and audit scope, the MDSAP Audit Model, Audit Task and Criteria and anticipate the expectations on the audit Findings, Certification and Post Audit Timelines.
24 июл 2024
