Episode Details

This is the audio from RQM+ Live! #42, originally recorded 28 October, 2021.
When we say RQM+ IVD Director Carlos Galamba is no stranger to the IVDR, we really mean he is no stranger to the IVDR! Carlos is not only fresh out of BSI, but was one of three technical managers developing their IVDR program. Since BSI covers close to 50% of the world’s top IVD companies, we think the perspective and experience Carlos brings to the table is absolutely invaluable.
This special edition of RQM+ Live! will be all about sharing his perspective and experience with you.
Having been in the unique position of 2 IVDR notified body designations at BSI, Carlos is completely in the know about how notified bodies are interpreting and implementing the regulation, and what IVD companies can sincerely expect from BSI and other notified bodies. We're unabashedly biased, but if you're in the IVD space, we think there are very few experts out there that would make for a better Q&A session around the IVDR than with Carlos.
Carlos will bring his top-asked questions that he's compiled from when he was with the notified body, and we encourage you to bring your own questions for him! He'll answer them live. When it's all said and done, we're conducting this session so we can help answer your questions, so don't be shy! We think you'll find that Carlos isn't.
Click here to read more about Carlos' notified body involvement and extensive background

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