Day: December 19, 2018
Public docket for comments – USFDA Proposes to End Temporary Extension of GUDID’s Grace Period
Survey regarding where members of Team-nB are in the MDR designation process – Team-NB is publishing a survey on the MDR designation process present stages in which Team-NB notified bodies member are. Pesquisa sobre onde os membros do Team-nB estão no processo de designação para o MDR – Team-NB is publishing a survey on the MDR designation […]
Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) New Manufacturer Incident Report helptext.
Here: NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application”
A new program focusing on “to encourage innovation and market entry of device technologies that are safer than current alternatives”. Read here: Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety […]
Interesting framework to evaluate the performance of regulators – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018. Framework interessante para avaliar o desempenho deTGA reguladores – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018.
Here – Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff