No products

To be determined Shipping

$0.00 Total

Check out

Product successfully added to your shopping cart

Quantity

Total

There are 0 items in your cart. There is 1 item in your cart.

Total products

Total shipping To be determined

Total

Continue shopping Proceed to checkout

New Reduced price! AAMI TIR102:2019

View larger

AAMI TIR102:2019

Reference: M00002570

Condition: New product

AAMI TIR102:2019 U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

standard by Association for the Advancement of Medical Instrumentation, 08/30/2019

More details

In stock

More info

Full Description

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.

Product Details

Published: 08/30/2019 ISBN(s): 9781570207242 Number of Pages: 146 File Size: 1 file , 1.1 MB