SoftwareCPR Standards Summary May 2014

A number of draft standards were released for comment, including including several related to specific security for medical devices and Health IT:

  • AAMI TIR38 – AAMI Medical device safety assurance case guidance
  • IEC Health SW Standards Framework
  • ISO 27799 Health informatics “Information management in health using ISO/IEC 27002”
  • IEC TR 80001-2-8, Application of risk management for IT networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
  • NIST Special Publication 800-160 Systems Security Engineering. This guidance infuses systems security engineering techniques, methods, and practices into the systems and software engineering processes defined in ISO/IEC 15288. This NIST document is publicly available at the link provided. NIST SP800-160 Draft

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.