Holly
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Spotted: Something new is here for our community!
We’re excited to share Monir El Azzouzi new MedTech magazine—a resource created to spotlight the latest QA/RA ideas, innovations, and voices shaping our industry.
At indieMedTech, we believe knowledge is best when it’s shared. This new publication is another way to bring the community…
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Holly created the group
6 months agoRegulatory 6 months ago -
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Kimberly are now connected 6 months ago -
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Holly replied to the discussion Available Cyber work in the forum Consulting 6 months ago
Hi Nick! I have someone who may be able to help – feel free to direct message me and I can make the connection!
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Reply to Definition of "clinical investigation"
It’s interesting that you say that because I actually have successfully helped manufacturers of Class IIB and III implantable legacy devices satisfy the requirements for clinical data with retrospectively collected data via PMCF. BUT they were also legacy devices so it would not necessarily support a new product being brought to market under MDR…
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Reply to Definition of "clinical investigation"
Hi Amie – this is absolutely spot on, and allows for effective use of retrospective studies for the purpose of PMCF that do not require EU oversight or prior ethics committee approval (there are of course limitations to this, but thats generally the case in most scenarios). The study does not impact clinical management of the patient, so…
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