Software Development

SaMD

Intro to SaMD

SaMD, or Software as a Medical Device, is not just another mobile app.  It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.

software testing

Software Testing Is Not Hardware Testing

Best practices for medical device HW testing are not best for SW testing Medical device development teams often ask me for help with software V&V. Even though they have their hardware development under control, these teams keep encountering software testing problems and the corresponding compliance documentation.  Frequently, it’s because their company’s quality system, explicitly or …

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Sunstone Pilot NewsletterHeader

Newsletter V. 2019 Issue 1

Embracing Change: Your Connected Medical Device is Never Finished Embracing change means setting up your organization, processes, and tools to efficiently manage changes during product development and after product launch. Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts of how to integrate risk management into the overall product …

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Heart rate monitor wearable

Embracing Change: Your Connected Medical Device is Never Finished

The proliferation of software in modern medical devices has enabled innovative new applications and many benefits to patients.  However, it has also created greater challenges for medical device companies: namely, managing greater product complexity and more reliance on third party software components.  For connected devices there are the added challenges of cybersecurity risks, protecting patient …

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Processes of the IEC 62304 software standard

FDA Software Guidances and the IEC 62304 Software Standard

“One approach to satisfy two sets of rules” for medical device software As stated in the last blog post, there are two sets of rules for medical device software—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the international IEC 62304 standard, which is easier to understand, and …

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