QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Town Halls Planned
Medical Device Expert News
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019
DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices
DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices
Notification of a Body in the framework of a technical harmonization directive – TÜV Rheinland LGA Products GmbH
Australian regulatory action on breast implants and breast tissue expanders
MITA UPDATES SERVICING AND REMANUFACTURING WHITE PAPER NEMA/MITA RMD P1-2019 – Considerations for Remanufacturing of Medical Imaging Devices
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR