AAMI TIR102:2019
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
30-08-2019
This document is a comparison of requirements between 21 CFR 820 and ANSI/AAMI/ISO 13485:2016 that demonstrates similarities, highlights differences, and discusses key considerations for medical device manufacturers.
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.