Full Description

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.

All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 08/19/2020 ISBN(s): 9780580971013 Number of Pages: 52 File Size: 1 file , 2.9 MB Same As: ISO/TR 20416:2020 Product Code(s): 30354762, 30354762, 30354762