Holly
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Holly and
Jarrell are now connected 2 months ago -
Holly replied to the discussion Available Cyber work in the forum Consulting 2 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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Holly and
Jyothsna are now connected 2 months ago -
Holly and
Jude are now connected 2 months ago -
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
2 months agoClinical Evidence 2 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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