The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis
Author: Dr. Suzanne Broussard One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and […]
The Summary of Safety and Clinical Performance (SSCP) is a Required Part of Medical Device Regulation (MDR) 2017/745: Is Your Organization Ready?
Author: Suzanne Broussard The Summary of Safety and Clinical Performance (SSCP) plays an important part of the very strong post-market follow-up required in MDR 2017/745 for implantable and class III medical devices. The SSCP is intended to provide healthcare workers and […]
The Summary of Safety and Clinical Performance (SSCP) Provides Valuable Information to Health Care Providers, Patients, and Manufacturers
Author: Suzanne Broussard Is your organization ready to display to the world your medical devices safety and performance record? The Summary of Safety and Clinical Performance (SSCP) is one of the new requirements imposed by manufacturers by […]