Journal Articles related to Medtech
Journal Article
- June 8, 2023
This article reviews the MEDDEV 2.7/1 Revision 4 requirements, with an emphasis on strategies to meet the individual requirements of specific regulators in one document. Key guidance on navigating the world of Clinical Evaluation Reports and the MEDDEV 2.7/1 Revision 4 are shared.
Journal Article
- February 21, 2023
With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns over widespread product shortages in the EU market have been growing.
Journal Article
- December 2, 2022
Manufacturers of medical devices must put in place a wide range of processes and documentation to meet post-market surveillance requirements. While this means more work, Belinda Dowsett of PharmaLex* explains that these requirements do give manufacturers better insight into the performance of their devices.