At first glance, risk management of diagnostic devices, including in-vitro devices (IVD), is not overly complex. After all, you mostly have to consider the effects of false negative results, false positive results, and invalid or delayed results.
However, it can be challenging to correctly assign the severity of harm(s) resulting from inaccurate and/or delayed results if we don’t fully understand the clinical context of the intended use of a diagnostic device.
In this episode, Joshua Levin advises risk practitioners to clearly define severity levels of potential harms directly in the risk management plan. This is especially valuable in a small company environment focused on developing a single device. He recommends a simple, more pragmatic approach to risk management for IVDs, driven by a solid understanding of the clinical context.
About Joshua Levin
Joshua Levin is a regulatory consultant, currently advising early-stage and mid-size companies in developing effective regulatory strategies and building efficient quality management systems, With 30 years of experience in the Quality/Regulatory space, including nearly 10 years at the US FDA, Josh has a deep understanding of both technical and regulatory aspects of IVD commercialization.
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 23: Focus on intended use in the clinical environment for risk management of IVDs