White Paper

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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Risk Management Series – Part 4: Key Terms

Risk Management Series – Part 4: Key Terms

Introduction Before diving into the best practices for conducting a risk assessment, it’s important to clarify some terminology. ISO 14971:2019 (the Standard) and TR 24971 (the Guidance) provide helpful definitions and examples, but even with that, the use of some...

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