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Ep 08: Understanding the interface between clinical evaluation and risk management
The medical device regulation in the European Union (EU-MDR) outlines many new requirements for conducting clinical investigations and clinical evaluation throughout the device lifecycle.
The challenge is that the term “clinical risk” is not clearly defined in the EU-MDR. This has created a lot of confusion in the medical device industry about the scope of clinical risks that need to addressed through a clinical evaluation and appropriately integrated with the risk management system.
In this episode, Alexej Agibalow explains how the clinical evaluation process and risk management are interconnected, and recommends a cross-functional, collaborative approach to fully understand various interfaces and synchronize activities between these processes.
About Alexej Agibalow
Alexej Agibalow is a risk management expert at Escentia GmbH and manager of risk and regulatory affairs at Drager.
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.
If you enjoyed this episode, consider becoming a free or paid subscriber to Let’s Talk Risk!.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe
View all episodes
By Casual and informal conversations about practical aspects of medical device risk management.
5
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The medical device regulation in the European Union (EU-MDR) outlines many new requirements for conducting clinical investigations and clinical evaluation throughout the device lifecycle.
The challenge is that the term “clinical risk” is not clearly defined in the EU-MDR. This has created a lot of confusion in the medical device industry about the scope of clinical risks that need to addressed through a clinical evaluation and appropriately integrated with the risk management system.
In this episode, Alexej Agibalow explains how the clinical evaluation process and risk management are interconnected, and recommends a cross-functional, collaborative approach to fully understand various interfaces and synchronize activities between these processes.
About Alexej Agibalow
Alexej Agibalow is a risk management expert at Escentia GmbH and manager of risk and regulatory affairs at Drager.
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.
If you enjoyed this episode, consider becoming a free or paid subscriber to Let’s Talk Risk!.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe
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