Devices used for the condition of temporomandibular disorders (TMD), including temporomandibular joint (TMJ) implants.
Posts published in November 2019
Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
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…
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…
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