ISO/TR 20416:2020
Current
The latest, up-to-date edition.
Medical devices Post-market surveillance for manufacturers
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
07-08-2020
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. The output of this process can be used:
as input into product realization;
as input into risk management;
for monitoring and maintaining product requirements;
for communicating to regulatory authorities; or
as input into improvement processes.
This document does not address market surveillance activities to be performed by regulatory authorities. Neither does it specify a manufacturer's actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.
Important note : All end users must be registered with an Account prior to user licenses being assigned.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.