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

Medical devices - Quality management systems - Requirements for regulatory purposes
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management ...
Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security speci ...
Document History
We have no document history for this standard.
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

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.