White Papers

White Paper – Proposed QMSR Expert Analysis (Part 1)

On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 1 of a series of...

Risk Management Series Introduction – Beyond FMEA

Forward:MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device and invitro diagnostic industry. The intent of the series is to provide practitioners with insight into how to...

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...
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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