Programme

2016, March

The Medical Device Single Audit Program (MDSAP) is a unique regulatory program intended to facilitate access to the US, Canada, Brazil, Japan and Australia; by offering the possibility to assess during a single quality management system audit, the 5 corresponding regulations. It is therefore particularly suitable for companies selling their medical devices in these markets.

This webinar’s goal is to provide you with an overview of the Medical Device Single Audit Program (MDSAP) and explore the challenges associated with it, particularly with regard to the future replacement of the Canadian program CMDCAS (Canadian Medical Device Conformity Assessment System) by MDSAP.

The topics discussed are:

  • Overview and objectives of the MDSAP
  • Why is it necessary to take a close interest in this program?
  • How does an MDSAP work?
  • MDSAP and CE marking

Experts

Corinne DELORMERegulatory Affairs Global Manager - LNE

Corinne DELORME is the Head of Regulatory Affairs in the field of medical devices at LNE’s Certification Directorate. As part of LNE / G-MED’s activities, Corinne DELORME is particularly involved in the development of the certification activities for the European, American, Canadian and Australian Regulations on medical devices and has been playing a key role in obtaining LNE’s corresponding accreditations.

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