The next RAPS TC Chapter event is on 28 November 2016 at Surly Brewing in Minneapolis. Registration details will be going out this week so be on the look-out for them!
This month's speaker is Tamas Borsai from TUV SUD America. He will be talking to us about the Medical Device Single Audit Program (MDSAP) "One Audit, Multiple Market Access" as well as giving us a BONUS presentation on "Overview of Legacy Products" (see descriptions below.)
Are any of your organizations considering participating in the MDSAP?
- If yes, what challenges are you facing in preparation for the audit?
- If no, what are the major contributing factors for not participating?
If you aren't able to attend the event, you can still participate!! Send me your questions on either topic for Tamas and I will post his response here.
Looking forward to seeing you soon!
Lena
MDSAP:
MDSAP is a program that will allow the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of multiple regulatory jurisdictions. Audits will be conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP. The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
Overview of Legacy Products:
Most guidances are aimed at new or recently developed products, as opposed to legacy products, which are products developed in the past but still exist on the market. The importance of knowing how to prove ‘state of the art’ for a legacy product becomes especially evident when technical files are renewed and reviewed more in depth by notified bodies.
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Lena Cordie
Qualitas Professional Services, LLC
Victoria MN
United States
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