2:27 Webinar recording excerpt
How does a medical device risk become a harm?
In December of 2019, ISO released a new version of their risk management regulation ISO-14971. The intent of the regulation remains unchanged but the ISO has made some changes to better define benefit and reasonably foreseeable misuse. An increased emphasis has been placed on post-production activities and what information needs to be collected and what actions should be taken when postmarket information is relevant to safety.
The presenters will review the concepts of risk, risk analysis, and how a hazard becomes harm. They will also discuss how risk analysis fits in with a manufacturer’s over-arching risk management activities.
Finally, view a brief demonstration of how a solution like Reed Tech Navigator™ for Medical Devices can speed up risk analysis activities by aggregating and analyzing post-market data for you.
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What’s Your Approach to Risk Management?
How are you currently tracking complaints, and are you treating it as an essential part of your device’s risk management lifecycle? We would love to hear more about your approach!
To continue the conversation, or learn more about Navigator for Medical Devices (and get a free two-day trial), reach out to our team at 215.557.3010 or MedDevice@reedtech.com.