Seminar: MDSAP

This seminar focuses on the Medical Device Single Audit Program, MDSAP.

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 Life & 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.

 
 

 
12:30 – 13:00
 
 Registration, sandwich and network  
 13:00 – 13:05  Welcome Lene Laursen, Deputy-Director, Medicoindustrien
 
 
13:05 – 13.10
 
Introduction to UL and Lead Auditor
Deborah Stubbs
 
 
Flemming Flindt, Senior Sales Executive,
Life and Health Sciences, UL International Demko A/S 

 

 
13:10 – 14:30
 
 MDSAP-presentation Lead Auditor Deborah L. Stubbs,
UL Life and Health Sceiences
 
14:30 – 15:00
 
 Coffee.

 

 
15:00 – 16:00
 
 
Q & A- session
Summary and conclusion 
Lead Auditor Deborah L. Stubbs,
UL LIfe and Health Sciences

 
 

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Kontakt

ll@medicoindustrien.dks billede
Lene Laursen
Vicedirektør
4918 4702