Dec 23 - 7:02
The Medical Device Coordination Group (MDCG), the advisory body of the European Commission, is composed of the representatives of all EU Member states and is entitled to provide clarification regarding the...
Dec 19 - 4:16
ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards Contents Brief Overview of ISO...
Dec 18 - 5:44
Switzerland is going to amend its current medical device regulations in response to the changes implemented by Regulation 2017/745 (MDR). Mutual Recognition Agreement Contents Mutual Recognition AgreementMDR...
Dec 17 - 6:47
The US Food and Drug Administration (FDA), the authority responsible for premarket approval of medical devices, issued updated rules replacing paper submission form with the electronic form. The Scope Of New Changes...
Dec 16 - 7:59
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification...
