Holly
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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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Holly created the group
9 months agoClinical Evidence 9 months ago -
Updates to the MHRA Clinical investigations for medical devices were published today, including a flowchart and additional guidance for when submitting clinical investigations conducted in the UK are required. Follow the links below:
- Updated webpage: …
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Reply to Event Announcement for this amazing forum!
Signed up – cant wait for this one!
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Has anyone heard of MDCalc? I just discovered this (courtesy of my physician assistant/army captain husband) – you can find standardized assessment tools along with their validation history etc. I am thinking this could be such an amazing tool for clinical data strategies!
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Felicia and
Holly are now connected 9 months ago -
Reply to Real-time AE Reporting
I am really interested to see if/how this impacts manufacturers reporting practices, especially considering all of the details are not usually available when the initial report is made. Something to keep a pulse on for sure.
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Reply to How to manage time with multiple clients?
Thanks Felicia! I was considering trying out Calendly – if anyone has experience with Calendly I would love to hear about it!
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Holly updated their profile 9 months ago
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