R&Q Intelligence Series: Medical Device Single Audit Program (MDSAP)

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Tuesday, March 28, 2017
1:00 pm – 2:00 pm

Location: Webinar

MDSAP can potentially offer a variety of important advantages.

While currently optional for FDA, it will be mandatory for Health Canada in January of 2019. Times will be busy with limited qualified registrars, ISO 13485:2016 implementation by March 2019, and EU MDR by 2020.

Attend this webinar if you want to understand MDSAP inside and out and be sufficiently prepared.

Having been on the receiving end of two MDSAP audits, special R&Q Intelligence Series guest Connie Hoy of Cynosure Inc. (recently acquired by Hologic) will describe her successful first-hand experiences and offer step-by-step practical advice on how to adequately prepare for MDSAP and be successful. Her recent real-world case studies provide the perfect examples of what to do and how to accomplish it.

During the session we will cover:

  • Brief background, description, and why the program was put into place
  • Who is impacted and when? (including what happens in the EU)
  • How is the program used by regulatory authorities?
  • What are the MDSAP audit and result review processes?
  • Pros and cons of participation
  • How to participate?
  • Auditing organization (BSI, TUV, Intertek) bottlenecking
  • Case studies featuring practical implementation
  • What to do: R&Q recommended next steps

When we're done, you'll leave with:

  • An excellent understanding of the MDSAP program
  • Knowing how it might impact your company
  • A clear understanding of your potential next steps
  • Practical tips and guidance for actual implementation

The final 10-15 minutes of the session will feature a question and answer panel with R&Q's Jake O'Donnell (Senior FDA Compliance Principal) and Mark Swanson (Director, Minnesota Operations), as well as Connie Hoy.

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