Date & Time
Oct 7, 2020 11:00am CET
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.
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.