Are you preparing to upgrade your device technical documentation to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If so, this webinar will provide best practices and meaningful tips for manufacturers with devices sold under CE marks. NAMSA EMEA regulatory expert, Vincent Legay, will explain how the EU MDR requirements supersede current EU MDD 93/42 and 2007/47 requirements as they relate to Biocompatibility throughout the full medical device lifecycle.
Also discussed will be information on the specific areas of the EU MDR that enhance ISO 10993-1:2018, as well as other guidelines that support EU MDR requirements for deeper assessment, reduction and control of Biological Risk as they relate to patient concerns.
Lastly, critical MDR information will be provided based on NAMSA’s many interactions with EU Notified Bodies and agencies pertaining to the newly expanded requirements.
Time will also be allotted for Q&A.
About the Presenter:
Vincent Legay, Phd, MBA, MTOPRA; Director of Regulatory Services – EMEA
Vincent Legay holds a PhD in Biology and an executive Masters of Business Administration (MBA), and currently serves as NAMSA’s Director of Regulatory Services – EMEA. He possesses over 15 years’ experience at NAMSA where he has been responsible for regulatory consulting across the entire medical device lifecycle continuum. This expertise includes management of sterilization, biocompatibility, risk management, clinical evaluation and quality management systems for clients around the globe. Currently, he oversees a team of regulatory experts across Europe and also directly supports medical device manufacturers with preclinical and clinical research approaches in an effort to meet regulatory business objectives.
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