Question
Many available sources of light therapy will deter the degeneration of Alzheimer's and TBI, non-invasively. However, until someone large enough to afford FDA approval undertakes the initiative, the tragic onslaught of dementia will continue. This vid...
With the new EU Medical Devices Regulation and IVD Regulation more or less established now, let's take a look at the transparency requirements under these regulations. This presentation was delivered at Informa's MedTech Summit in Brussels on 14 June...
source: https://www.linkedin.com/groups/78665/78665-6146716667671044098
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I am working with a start up, young energetic crowd, towards developing a new medical device. First version is off-the shelf monitor, not going for FDA approval. But later versions will aim for it. Nonetheless, it is to be used for monitoring infant ...
FDA issued "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" this week. Group member Glenda Guest included the link at and began a discussion about it. Among the changes are guidance on the appropriate use o...
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As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
