By

Ron Baerg
Shepherdly: A bug prediction & code resilience coverage tool In the context of software development, Resilience Coverage measures the overall protection a pull request has against bugs that can impact large portions of your user base and/or expose observability gaps. When coupled with a Software Quality Risk Score driven by a predictive model, engineers can...
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FDA Draft Submission Guidance AI/ML For Use of AI/Machine Learning-Enabled Device Software Functions Almost every day there is another news story about something involving “artificial intelligence.” So it seems timely that the FDA has just released a draft guidance for Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...
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A January 2014 ACM Journal has an interesting article on software verification at NASA JPL for the Mars Curiosity Rover at the link provided. A few things that I found interesting: Their standard for flight software is ISO-C99. The coding standard at JPL (http://lars-lab.jpl.nasa.gov/JPL_Coding_Standard_C.pdf) is risk-based and has 6 “levels of compliance”. LOC-5 and LOC-6...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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