[FREE WHITE PAPER] Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
Overview This white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in […]
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 […]
