2 min reading time

How’d you like to have one audit instead of four?

In an effort to accelerate international medical device regulatory harmonization and convergence, the International Medical Device Regulators Forum (IMDRF) developed common standards for quality management audits, recognized by multiple participating countries.

It’s called the Medical Device Single Audit Program (MDSAP) and I found one of the most experienced practitioners to explain its benefits to you in a free webinar on April 28 at noon Eastern time.

See http://medgroup.biz/mdsap to register for the free event.

The webinar will cover the impact of the Medical Device Single Audit Program on Medical Device Manufacturers selling into the USA, Canada, Brazil or Australia.

TÜV SÜD expert Edna Falkenberg will cover:
• Benefits of participating in the MDSAP pilot program
• How to satisfy multiple regulatory jurisdictions at once
• The MDSAP forms you’ll need
• How to prepare for MDSAP

It’s a long list. See http://medgroup.biz/mdsap for the whole agenda.

My friend Dick DeRisio told me, “If I were still in industry running QA/RA for a U.S. multinational medical device company, I’d be all over this program.

U.S. companies are likely reluctant to take the step because they believe that it’s an FDA-dominated ‘tool’ to get into manufacturers every year instead of biennially and a way to peek into management review notes and internal audit results, which are typically off-limits during FDA inspections. But that view is very shortsighted.

Companies are waiting for 4 to 5 years for a Brazil ANVISA audit so they can market in Brazil. With MDSAP, they get it now. Health Canada reportedly will rely on MDSAP only in 3 to 5 years. So you can have an ANVISA audit, an Australia TGA audit, an Health Canada audit, and FDA audit, or participate in MDSAP. I know which route I’d choose.”

My thanks to TÜV SÜD for sharing this with the group.

That link again: http://medgroup.biz/mdsap

We’ll send you the replay, slides, and transcript even if you can’t make the live broadcast.

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Dr. Peter Havel from TÜV SÜD will discuss Global Market Access – A Pathway to Profitability, ways to find success outside your home market at 10x, our annual meeting in four weeks.

He’ll be joined by Gemma Moore, Vice President of International Regulatory Affairs for Edwards LifeSciences.

Only 45 seats remain for the May 4 event so act today if you’re interested.

http://medgroup.biz/About-10x

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Discussions

How do we measure design quality to mitigate risk?

Effective risk analysis

List of Medical Education & Bioskill Lab service providers

Are Latin American meddev distributors ready for consolidation?

Alternatives to ‘Latex Free’ labelling

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Maitri Tanna
Clinical Solutions Analyst
Looking forward to the webinar! Thank you for sharing.

D.M.F.A K
President
Thanks.

Mark Swanson
Principal Quality and Regulatory Consultant
Looks like a great source of information on MDSAP. I look forward to this webinar.

James (Jim) Dent
Manufacturing Validation Enginee at DePuy Synthes Companies
Thanks.

Karen Boyd
Owner / Operator at QMS Consulting LLC
Sounds great! Thanks for sharing the info, Joe.

Fatmir Mulaj
Assembly Final Test Worker på Baxter International Inc.
Very Interesting, thank.

Krista Xiomara Alvarado
Clinical Project Manager at Forbius
Very Interesting, thank you for sharing Joe!!!

Dave Sheppard, CMAA
Global M&A, OutSourced B,D&L Leader for SME (Small and Medium Enterprises) & Emerging Technology Healthcare Companies
Joe, great reminder about the MDSAP program ! I’m with you – it’s a great opportunity for multi-national Med Device companies. I’m looking forward to the webinar !