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Regulatory

EUDAMED Database – Progress Updates

EUDAMED Database – Progress Updates

EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The European Database for Medical Devices, or EUDAMED, is intended to store and provide...

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White Paper – Transition Plan for COVID19 EUAs

White Paper – Transition Plan for COVID19 EUAs

White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency. The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the...

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