Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 46: Tips to boost effectiveness of medical device post-market surveillance
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LTR 46: Tips to boost effectiveness of medical device post-market surveillance

Insights from a Let's Talk Risk! conversation with Taylor Dieringer

“Risk management is often seen as a check the box activity”.

Taylor Dieringer reminds us in this Let’s Talk Risk! conversation that risk management should be an ongoing, continuous process within your quality management system, that monitors, evaluates and controls risk throughout the product lifecycle, and not just in the pre-market phase.

The post-market surveillance process serves as a link between real-world safety performance of a medical device and design and development of new products to achieve this objective.

Listen to this Let’s Talk Risk! conversation with Taylor Dieringer, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.

00:02:30 Introduction

00:04:03 What is post-market surveillance and why it is needed

00:06:51 Post-market surveillance process is a continual learning process

00:08:05 Setting thresholds for action during post-market surveillance

00:11:00 How to detect and evaluate safety signals

00:13:40 Why we need a cross-functional team for post-market surveillance

00:16:37 Audience Q&A

00:30:05 Closing comments and key takeaways

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About Taylor Dieringer

Taylor Dieringer is currently a staff quality engineer at iRhythm Technologies, Inc. where he leads risk management activities throughout all phases of the product lifecycle, ranging from design to post-market surveillance. He is a biomedical engineer by training with prior experience in design and development, quality assurance and risk management at multiple medical device organizations.

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.

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Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!