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Oct 7, 2020
  • Webinar

QMS vs IVDR: Manufacturer Obligations and Auditing Impact

Gain an overview of the upcoming changes expected with the new IVD regulation.

One male and one female scientist working in a laboratory

Date & Time

Starts

Oct 7, 2020 11:00am CET

Ends

12:00pm CET

Location

Online

The new IVD regulation specifies certain obligations that a manufacturer (and other applicable Economical Operators) cannot miss, including design and manufacturing, risk management, clinical evaluations, UDI, quality management system (QMS), post-market and surveillance activities. 

This webinar aims to provide clear and unambiguous directions to manufactures in order to meet upcoming expectations and ensure no disruption of availability of medical devices on the CE market.

Speaker:
Maurizio La Mura is an IVD Specialist at UL, where he works on CE marking as well as QMS Certification programs. In this position, he supports IVD Manufacturers on meeting Regulatory and Quality requirements to ensure safe and effective IVD medical devices on the market.

Maurizio has worked with reputable Diagnostic Firms, including QIAGEN and  University of Cambridge, among others. He has played Lead rules on the development of innovative as well as well-established IVD platforms.
 

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