MDR 10.4.1: What Should We Really be Doing to be Prepared?

Release Date
July 19, 2019 10:30 AM ET U.S.

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In this webinar, NAMSA’s regulatory and testing experts will discuss the restricted materials compliance sections of the Medical Device Regulation (MDR), specifically Section 10.4.1-Substances. As outlined in this guidance, manufacturers are to reduce risk posed by substances or particles that may be released from a device; however, what does this really mean in practice, and how might sponsors adequately reduce risk?

Provided throughout this webinar will be guidance and answers provided for these common questions:

Time will also be allotted for Q&A.

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About the Presenters:

 

Don Pohl

Principal Product Development Strategist, NAMSA

Don holds a Bachelor’s degree from Ohio State University. He has over 25 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.

  Dr. Sylvie Framery

Senior Principal Medical Research Scientist, NAMSA

Dr. Sylvie Framery holds a Ph.D. in Biology from the University of Rennes (France). Her primary expertise is in the field of Biocompatibility/Toxicology, with more than 10 years of laboratory experience in NAMSA, in Lyon, France. She has spoken and published in several conferences/Seminars and international newspapers. Today, she serves as a Consultant specializing in biomaterial safety issues.

  Adrian Keene

Director, EU Consulting Services, NAMSA

Adrian utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He has worked with a broad range of devices, including drug-device combination products. Adrian was previously the Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In total, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation