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

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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