by Federica Secchi | Aug 26, 2019 | Blog, MDR Medical Device Regulation
Medical Device Classification in the EU MDR One of the first considerations for medical device manufacturers who are seeking to place their products in the European market is to determine which is the appropriate classification for their devices. The classification...
by Federica Secchi | Aug 11, 2019 | White Papers
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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 28, 2019 | White Papers
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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...
