Month: November 2019
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