Episode Details

This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021.

The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples:

No, you should not reclassify all of your Class I devices to Class Ir to gain extra time; classifications need to be done correctly No, you should not start calling your medical device software not a medical device to avoid compliance No, you should not ignore your non-medical accessory software that's part of your system when implementing the MDR. The notified bodies are not letting this pass. No, you should not start with a weak PMS plan to enable hitting the target date with an intention to revise before your next surveillance audit. 

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