Customer Service:
Mon - Fri: 8:30 am - 6 pm EST

 Most recent

ANSI/AAMI/ISO 13485:2016 Handbook

Medical Devices - A Practical Guide, Advice from ISO/TC 210

AAMI has adopted this companion handbook to ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes. It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. This resource replaces ISO 14969. AAMI/ISO 13485:2016, Medical devices - A practical guide, offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.


Content Provider
Association for the Advancement of Medical Instrumentation [aami]


Others Also Bought

ANSI/AAMI/ISO 13485:2016 (R2019)
Medical devices - Quality management systems - Requirements for regulatory purposes.
ISO 14644-1:2015
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle conc ...
AAMI TIR102:2019
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management ...
ANSI Logo

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS