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U.S. FDA’s Latest Requirements for the 510(k)

U.S. FDA’s Latest Requirements for the 510(k)

U.S. FDA’s Latest Requirements for the 510(k) Presented by John Lincoln, EAS Independent Consultant April 19, 2022 at 1pm eastern The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and...
Medical Device Product Risk Management

Medical Device Product Risk Management

Medical Device Product Risk Management Presented by John Lincoln, EAS Independent Consultant February 28, 2022 at 1pm eastern Both the U.S. FDA and the EU’s MDR require product risk management as part of virtually all regulatory compliance efforts. Companies...