Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. Manufacturers around the world are recertifying to the new standard, which emphasizes risk management as a key component of quality management systems. EN ISO 14971:2012 defines risk management processes for medical device manufacturers. But, implementing ISO 14971 can be intimidating. In this webinar, Dr. Dieter Dannhorn breaks down the requirements of ISO 14971 compliance and explains how to strategically implement the standard into your quality system. You will learn:
• Key definitions of EN ISO 14971
• A breakdown of the risk management process
• Components of the risk management plan
• Personnel and responsibilities in the risk management process
• How to define the risk of your device
• What is a risk management report and risk management file
ABOUT THE PRESENTER:
Dr. Dieter Dannhorn is a Senior Expert for Medical Devices at UL's medical device testing division in Germany. Dr. Dannhorn has over 25 years of experience in the medical device and pharmaceutical industries, particularly in the areas of clinical research, device testing, biocompatibility, registration support, and risk management. He was the previous owner of mdt medical device testing GmbH and md registration support Ltd., which were purchased by UL in 2011. He has worked as a freelance consultant and expert for UL since 2013 and received his doctoral degree in cell biology and anatomy from The Phillip University of Marburg in Germany.
Want a copy of the webinar slides? Click here to download the PDF.