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QMSR: Expert Analysis - Part 2 White Paper

QMSR: Expert Analysis - Part 1 White Paper

Transition Plan for COVID19 EUAs - White Paper

EUDAMED Database – Progress Updates

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...

White Paper – Transition Plan for COVID19 EUAs

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...

The FDA and Medical Device Cybersecurity

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...