Observation 1 – This is the third installment of my series on medical device clinical evaluation. I suggest reading the first part at (http://www.medicaldevice.expert/) to have a better understanding of the concepts so the understanding of this part is easier). The Clinical Evaluation Report – CER is the document which contains the results of the […]
Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
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 about the need and how to use critical thinking applied to EBP (and it also applies generally to any need of critical thinking). Recommended reading!
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 of medical devices – Part 1 – Overview and sample of activities – http://www.medicaldevice.expert/europe/european-commission/medical-device-regulation/how-to-perform-a-clinical-evaluation-of-medical-devices-part-1-overview-and-sample-of-activities/0 to have a better understanding of the concepts so the understanding of this part is easier). […]
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 of an NB in the conformity assessment procedure and thus a valid CE certificate).
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 and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices […]
TGA presentation: Cybersecurity for medical devices