Software Development

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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