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Category Archives: Software Quality
OTS/SOUP Software Validation Strategies
My last discussion of Off-The-Shelf software validation only considered the high-level regulatory requirements. What I want to do now is dig deeper into the strategies for answering question #5: How do you know it works? This is the tough one. … Continue reading
Building Safety into Medical Device Software
The article Build and Validate Safety in Medical Device Software takes a critical look at the current processes for medical device software and concludes: The complexity of the software employed in many medical devices has rendered inadequate traditional methods (testing) for demonstrating … Continue reading
Posted in FDA, Medical Devices, Software Quality
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Discomfort with Computerized Medical Devices
Here are some thoughts regarding the article: I feel a little uncomfortable about computerized medical devices, and here’s why. Just about all medical devices are computerized these days. Most will not harm or kill you if their software fails (Class … Continue reading
Agile Software Development in Regulated Environments
As part of a series on High Assurance Agile Development in Regulated Environments is the article Agile Software Development in Regulated Environments Example: Medical Devices. The purpose of this article and future posts is to introduce the FDA regulatory landscape and … Continue reading
Technical Debt in Medical Software
Software development is software development. Most of the life cycle and quality issues faced in medical software are the same challenges for any software product. Technical Debt in Medical Software points out what technical debt is: Complexity Code Duplication Documentation … Continue reading
Posted in FDA, Programming, Software Quality
Tagged Architectural Debt, Documentation Debt, Testing Debt
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ISO 62304: The Harmonized Standard for Medical Device Software Development
The FDA approved ISO 62304 as a recognized software development standard in 2009. Developing Medical Device Software to ISO 62304 gives a nice overview. Besides providing a globally accepted development process one of the other practical components is the assignment … Continue reading
The Software Quality Balancing Act
Andrew Dallas’s article Caution: V&V May Be Hazardous to Software Quality touches on a number of good points regarding software quality best practices. Medical device software development V&V (also see here) and the documentation that goes with it have substantial … Continue reading
Posted in Agile, FDA, Medical Devices, Software Quality
Tagged software verification and validation, V&V
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To Validate and Verify: Software Issues Solved
Yours truly was interviewed for this article: To Validate and Verify: Software Issues Solved “V&V” is one of those topics that should be simple to understand, but for some reason is the source of a lot of confusion. This is … Continue reading
Guest Article: Static Analysis in Medical Device Software (Part 3) — Formal specifications
The third and last guest post by Pascal Cuoq on software verification. This part is about formal specifications. Continue reading
The Challenges of Developing Software for Medical Devices
Developing Software for Medical Devices – Interview with SterlingTech gives a good overview of the challenges that especially face young medical device companies. In particular (my emphasis): Make sure that your company has a good solid Quality System as it … Continue reading
Posted in FDA, Medical Devices, Programming, Software Quality, Tools
Tagged Methods-based verification, static analysis
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