by Federica Secchi | Jul 29, 2019 | Blog, MDR Medical Device Regulation
The Role of a PRRC (Person Responsible for Regulatory Compliance) in the EU MDR The New EU MDR that will go into effect in May 2020 requires medical device companies to appoint a Person Responsible for Regulatory Compliance (PRRC). The PRRC does not replace the...
by Federica Secchi | Jul 7, 2019 | Blog, MDR Medical Device Regulation
The MDR Countdown The new EU Medical Device Regulation (MDR) will create a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers. Manufacturers need to...
by Federica Secchi | Jun 16, 2019 | Blog, MDR Medical Device Regulation
Will Your Notified Body Be Ready for Your EU MDR Certification? With the May 26, 2020 enforcement deadline for compliance with the Medical Device Regulation (EU MDR) approaching and the uncertainty of Brexit, medical device manufacturers and regulatory professionals...
by Federica Secchi | Jun 5, 2019 | Blog, Certification, MDR Medical Device Regulation
ECM’s Milestone Towards New Medical Device Regulation (MDR) 2017/745 Certification Medical device manufacturers are now focusing their attention on their transition plans to the new MDR regulations which becomes mandatory on May 25, 2020. In addition, some...
by ecmamerica | May 9, 2019 | Blog
FIME EXPO Spurs Medical and Healthcare Innovation in June FIME (Florida International Medical Expo) will host its 29th show at the Miami Beach Convention Center in Miami Beach, Florida from June 26-28, 2019. FIME’s reputation takes top spot among medical and...
by ecmamerica | Mar 28, 2019 | Blog
Countdown to Brexit If your medical devices are CE certified by a British Notified Body, the wisest choice could be to transfer the CE to a Notified Body based in the Union, to avoid regulatory troubles and any other issues related to a no-deal scenario. ECM is a...
