BS PD CEN ISO/TR 20416:2020
Medical devices. Post-market surveillance for manufacturers
- Standard No.
- BS PD CEN ISO/TR 20416:2020
- Release Date
- 2020
- Published By
- British Standards Institution (BSI)
- Lastest
- BS PD CEN ISO/TR 20416:2020
- Scope
- This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities.
BS PD CEN ISO/TR 20416:2020 history
- 2020 BS PD CEN ISO/TR 20416:2020 Medical devices. Post-market surveillance for manufacturers