“The regulatory landscape is changing significantly and it is too hard to keep up.”
That is why Jennifer Mascioli-Tudor advises risk practitioners to be “super proactive” in following these rapid changes, understand the impact, and take a leading role in preparing their organizations.
In this Let’s Talk Risk! conversation, we focus on three big trends in MedTech - the shift from Quality System (QS) regulation to Quality Management System Regulation (QMSR), a new regulatory focus on cybersecurity in medical devices, and shifting regulations of lab developed tests (MDT).
Listen to this Let’s Talk Risk! conversation with Jennifer Mascioli-Tudor, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.
00:02:30 Introduction
00:04:00 Trend 1: Shift from QSR to QMSR in the US
00:07:40 Trend 2: Regulatory focus on cybersecurity in medical devices
00:10:30 Trend 3: Regulating Lab Developed Tests (LDT) in the US
00:13:10 General discussion: Learning opportunities at universities
00:33:07 Closing comments and key takeaways
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Suggested links:
UC San Diego: Regulatory Affairs for Medical Devices
Drexel University: Doctoral program in Biomedical Engineering
About Jennifer Mascioli-Tudor
Jennifer Mascioli-Tudor is currently the Founder and Principal Consultant at JMT consulting offering advisory services to MedTech startups and small manufacturers in business, regulatory and quality management strategy. She is also an instructor at UC San Diego where she teaches regulatory fundamentals and design controls. Her industry experience includes leading roles at J&J, Boston Scientific, Medtronic and GE. She holds a B.S. degree in Physiology/Chemistry/French, and an MBA in Global Business Management.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 53: Three big trends to watch in MedTech