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.
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!