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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Entry 01/15/2013 
FR Recognition Number 13-35
Standard
ANSI AAMI  SW87:2012
Application of quality management system concepts to medical device data systems
Scope/Abstract
This recommended practice provides information that will allow the medical device data system manufacturer to implement a quality management system that is commensurate with the risk presented by the device, the complexity of device and manufacturing processes, and the complexity of organization.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005

Guidance for Off-the-Shelf Software Use in Medical Devices, September 1999

Guidance Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002

Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 2005

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Lisa Simone
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2591
  Lisa.Simone@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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