Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast.

We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic). 


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We suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices. 

Another helpful guidance document is TR 24971 (Yea it’s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it’s good to know the European version as well. 

FMEA is another popular risk management project tool and there are others available.

We then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma.

From a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then the manufacturer can be held to a higher level of liability.

We dive deeper into the topic as we discuss:

  • Setting a strategy regarding limiting discussion on use
  • The difference between intentional and unintentional off-label use
  • The meaning of unintentional misuse
  • Staying focused on the intended use of the product
  • When to push back with regulators

Risk management can be overwhelming if you let it.  Approach it from a process point of view and understand the documentation suggested. 

greenlight.guru is about to make following risk management so much easier, featuring a module that allows you to conduct risk management activities and integrate with design control activities all in one, cloud-based solution.

Your hosts today for the Global Medical Device Podcast,  Jon Speer and Michael Drues Ph.D thank you for listening as they continue to share how you can implement their proven strategies at your organization.

About Our Guests:

Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences.

Jon Speer is co-founder and resident “Guru” at greenlight.guru, making waves with his innovative approach to QMS software being built exclusively for the medical device community.

About The Global Medical Device Podcast:

 The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Read the Definitive Guide to ISO 14971