Risk Benefit Analysis and Residual Risk are Key Components of ISO 14971:2019
Author: Nupur Srivastava, PhD | December 7, 2020 The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is […]
Medical Device Manufacturers Transitioning to ISO 14971:2019 Need to Perform a Gap Analysis and Create a Cross-Functional Risk Management Team
Author: Nupur Srivastava, PhD | November 18, 2020 There has been a lot of discussion on the updated International Organization for Standardization (ISO) 14971:2019, and experts agree that medical device manufacturers need to perform a gap […]
FDA Experts Provide Tips to Eliminate eCopy Holds for Premarket Submission Applications: FDA Touts eSTAR Development
Author: Suzanne Broussard, PhD | October 12, 2020 Up to 7% of premarket submissions are placed on eCopy Hold. At a recent public workshop, FDA experts provided multiple tips to device manufacturers to avoid this trap and get their submission accepted the first […]
