AAMI Standards Conference Software Session

At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray, of the FDA’s Office of Science and Technology and leader of the FDA’s Software STG, described FDA’s interest in standards for software development including a desire to decrease the software documentation required in submissions. Mr. Murray indicated that the Software STG recommended recognition of UL 1998 (a standard for software safety in programmable devices) and the specifics of their recommendation would make this the first FDA recognized software standard that would be applicable to devices with a major level of concern (hazard).

**** Slides from several of the speakers are attached in a single pdf. It currently includes the presentations by John Murray of the FDA, Alan Kusinitz of SoftwareCPR on the AAMI Software Standard, Stan Hamilton of Cytometrics on the Off-the-shelf Software Guidance, Susan Gill of UL on UL 1998, and Sherman Eagles of Medtronic on international standards related to medical device software. These are provided with the permissions of AAMI and the authors.

AAMI Stds 300 SW Presentations


Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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