U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

Publisher:
Association for the Advancement of Medical Instrumentation

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

This document provides a mapping of the US FDA 21 CFR requirements to the "regulatory requirements" references in ISO 13485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.

File Size :	1 file , 1.1 MB
ISBN(s) :	9781570207242
Note :	This product is unavailable in Belarus, Russia, Ukraine
Number of Pages :	146
Published :	08/30/2019

AAMI TIR102:2019 PDF

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

History

Related products

Best-Selling Products