Newsletters

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 …

Newsletter V. 2019 Issue 1 Read More »

Sunstone Pilot NewsletterHeader

Newsletter V. 2018 Issue 2

FDA Software Guidances and the IEC 62304 Software Standard There are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard and then include any additional adjustments needed to meet all the FDA requirements. This article details exactly what …

Newsletter V. 2018 Issue 2 Read More »

Sunstone Pilot NewsletterHeader

Newsletter V. 2018 Issue 1

Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” This article is designed for people who are new to medical device software—either experienced with software but not medical device regulations or experienced with medical device hardware only. Why is software special? References on medical cybersecurity for …

Newsletter V. 2018 Issue 1 Read More »