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Fri Oct 6
  • Seminar

UL SEMINAR: Medical Device Single Audit Program (MDSAP)

  • Seminar

MDSAP Seminar by Deborah Stubbs, UL's Health Sciences division at Medicoindustrien, October 6th, 2017

The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions, including Health Canada, US FDA, Japan PMDA, Brazil ANVISA and Australia TGA. As part of the program, audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities under MDSAP requirements and are accepted in lieu of each regulators' own Inspection or Audit.

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. The program's main mission is to "…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers."

Deborah L.Stubbs, Lead Auditor and Regulatory Lead Reviewer at UL's Health Sciences will be presenting a seminar for Medicoindustrien to share her expertise in establishing UL as a MDSAP Recognized Auditing Organization and to answer questions relating to the relationship between the MDSAP and the participating authorities including Health Canada's tight deadline Jan 1st 2019.

We invite you to attend the seminar in person and are extending a special 50% discount off registration for non-members.

Date: October 6, 2017

Time:12:30 – 16:05

50% discounted Non-Member Price: 1.500 kr.

Location: Søhuset Venlighedsvej 10, DK-2970 Hørsholm

Please reference "UL" when registering to receive this discount

Click here to view the agenda and register. https://medicoindustrien.dk/events/150

If you are unable to attend the seminar and would like to learn more about MDSAP, visit MDSAP web page, which also has links to resources such as white papers and FDA training modules, or contact us at: [email protected]

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