A PRRC with experience You can study the theory for every job, and this should be part of your preparation, but the theory will not provide you with experience. Becoming an experienced PRRC means that you have to learn from mistakes. But that doesn’t mean that you have to make these mistakes yourself. You can … Read more
I was looking for PRRC training for the SOPHiA Genetics team that would be practical and provide more insight than repeating what I can read. I was searching for someone with real-world experience that could be applicable to our situation and we found it in Ronald. There were other training offers, but Ronald customized this … Read more
This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
This section is about: Regulation (EU) 2023/607 Regulation (EU) 2023/607 on MDR transitional arrangements allows for manufacturers of devices that were certified under the ‘old’ Directives to remain certified as such for some years to come, while they wait until they become certified under the MDR. In general, this will require the manufacturer to prepare … Read more
PRRC scenario, as posted on LinkedIn on 8 February 2023 According to MDCG Guidance 2021-25 on legacy medical devices, the PRRC is not required for legacy devices. With that in mind, a freshly appointed PRRC had a fairly easy job; the company was not MDR certified yet. With the current proposal of the European Commission … Read more
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