Regulatory expectations for medical device risk management are evolving toward the need for “mature” systems and processes. Recent standard revisions also emphasize patient safety - a key enabler for participating in new and emerging regulatory schemes, such as the MDR and the FDA Digital Health Software Pre-Cert Program. To meet these expectations, device companies must learn to leverage risk management tools to improve patient outcomes, as well as patient and user benefits.
A mature risk management system satisfies more than the moral imperative of reducing risk for patients and users. It can increase device sales and customer loyalty, reduce the chance of product liability claims, and reduce your time to market. In this webinar, Mark Leimbeck will discuss how the regulatory environment is changing and what this means for your company. You will learn:
- A general overview of ISO 14971
- How specific standards reflect new risk management expectations, including IEC 60601 – Medical Devices, ISO 13485 – Quality Management Systems, IEC 62366 – Human Factors Engineering, IEC 62304 – Software, and more
- Areas of your risk management system that will receive more scrutiny from regulators
- What this new era means for post-market surveillance and your suppliers
ABOUT THE PRESENTER:
Mark Leimbeck is a Program Manager for UL Health Sciences with more than 30 years of experience working in roles including Operations Manager, Program Manager, and Principal Engineer. He is responsible for developing new services, training, and representing UL on International standards and other technical development committees. Mark holds a bachelor’s degree in Electrical Engineering Technology from Southern Illinois University and a master’s degree in Business Administration from the University of Chicago.