EU post-market obligations for medical devices
How Regulation (EU) 2017/745 governs post-market surveillance, PSURs, vigilance reporting deadlines and field safety corrective actions for medical devices.
Tag: postmarket
2 posts
FDA post-market obligations for medical devices
How 21 CFR Parts 803, 806 and 822 govern adverse event reporting, corrections and removals and ordered postmarket surveillance for US devices.