Related to my post yesterday about medical device clinical evaluation and EBP (Evidence-Based Practice), this recent book (published late last year) is already a classic…
Medical Device Expert News
EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands
NB 2797 – BSI Group The Netherlands B.V. – Netherlands
NB 1912 – DARE!! Services B.V. – Netherlands
This is the second installment of my series on medical device clinical evaluation. I suggest reading the first part (How to perform a clinical evaluation…
Danish Medicines Agency Ramps Up Capacity in Medical Devices
Here is a table to help you identify if your device is under the definition of Reusable Surgical Instrument (and thus would require the involvement…
The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality…
TGA presentation: Cybersecurity for medical devices