Hi, Vinoda,
I posted a similar question a few weeks back. None of the suggestions panned out. Be sure to call 1st rather than spend time filling out the applications just to get the come back in 2 years response.
I am working with 2 small companies in a similar situation trying to get a NB for CE marking.
Our new strategy is to apply with another NB but just for ISO 13485 and MDSAP. Some of the NBs have resources for ISO 13485 available now even if they do not have resources for MDR CE mark auditing open now. This way we will have the QMS set up and audited. We will also have a NB that is familiar with these companies so that as the MDR resources open up it will not be a big step from zip to full MDR CE marking.
While I can't respond to your question about DNV and DQS, I did want to mention an alternative strategy to get where you want to go.
Best regards,
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John Minier RAC
Consultant, Principal
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Original Message:
Sent: 17-Oct-2022 15:32
From: Vinoda Palanisamy
Subject: Choosing a Notified Body for MDR - Start-up
My company is currently working for MDR registration. It is small company - Start-up kind and has been in research for a while. This is the first time CE marking and market entry for the products. We had initially chosen Intertek, however now they have a huge backlog and isn't available till 2024. Same with BSI and Eurofins (undefined Timelines).
We are now looking at DNV and DQS NB for CE certification.
The product in scope for CE marking is AI-Software as Medical device. Company also manufactures, Class I Imaging devices and Class Im software. .
I was hoping to learn a bit more about some of your experiences with these Notified Bodies.
Have you experienced any issues with these NBs? Any recommendations or suggestions regarding the availability of other Notified Bodies are welcome! Positive feedback is also appreciated.
Thanks,
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Vinoda Palanisamy
Princeton NJ
United States
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