An estimated 185 people registered for the ELISA Summit, which took place virtually on September 7-8 to gather Linux community members and attendees from around the world. The event, which featured 15 sessions and 20 speakers, was open to anyone involved or interested in defining, using, or learning about common elements, processes, and tools that can be incorporated into Linux-based, safety-critical systems amenable to safety certification. Members of the ELISA Project community presented best practices and overviews on emerging trends and hot topics to using open source software in safety-critical applications and detailed working group updates.
We’ll be featuring event videos in blogs each week. Today, we focus on a session presented by the team members from ELISA Medical Device Working Group: Jason Smith, Jeffrey (Jefro) Osier-Mixon, Kate Stewart, Milan Lakhani,Nicole Pappler, Shefali Sharma, Shuah Khan on the topic of Medical Device Working Group update.
The main goal of this working group is to develop best practices to analyze systems and identify the components of Linux that will be participating in safety analysis, in the context of medical device safety standards. The main activities include
- Analysis of open source medical device application (openAPS)
- Create documentation of results of STPA analysis (system, requirements, architecture, design, …)
- Comparison of results of STPA analysis to 62304 Software of Unknown Provenance (SOUP)
- Create documentation on usage of tooling to support kernel analysis
In this session, the team shares progress to date, as well as some of the lessons learned and areas where they could use some help. The deliverables being worked on for the next quarter will be previewed as well.
Watch the video below or check out the presentation materials here.