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Jun 24, 2022 | Regulatory
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...
Jun 14, 2022 | Regulatory
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...
May 20, 2022 | Risk Management, News
With everything from cars to pacemakers now susceptible to cyberattack, questions about how safe our data is have come to the forefront. The Food and Drug Administration (FDA) is one of the organizations taking these concerns seriously, working to ensure that medical...