Author: Marcelo Antunes
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) – Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) – Meeting date: 4 November 2019
FDA approves first contact lens indicated to slow the progression of nearsightedness in children
FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection
Devices used for the condition of temporomandibular disorders (TMD), including temporomandibular joint (TMJ) implants.
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 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