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 […]
Notified Bodies Received New Guidance from MDCG on the Use of MDSAP Audit Reports for MDR and IVDR
Author: Dr. Suzanne Broussard | September 28, 2020 Medical device manufacturers received clarification on how the European Commission’s Medical Device Coordination Group (MDCG) will allow Notified Bodies (NBs) to use Medical Device Single Audit Program […]
[FREE WEBINAR] A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
Get a copy of the slides from this webinar or click to watch the recording. With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal […]
