Warm Wishes from Sunstone Pilot
I’m enjoying the New England snow! Warm wishes for a happy holiday season.
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SaMD Documentation Map
This SaMD Documentation Map illustrates the formal documentation needed for a typical Software as a Medical Device (SaMD) product. The map is a graphical representation of the interdependencies of the product documentation and what is needed for an FDA 510(k) submission.
SaMD Documentation Map Read More »
Featured in MPO Magazine – What Makes Complex Medical Devices Different?
Russell Singleton and I have seen many development projects that go awry for complex medical devices. Read our first MPO Magazine article about a different development approach.
Featured in MPO Magazine – What Makes Complex Medical Devices Different? Read More »
Re-Entrant Design Controls: Managing Medical Devices That Are Never Finished
Re-entrant design controls provide a systematic and efficient way to manage upgrades to a medical device over the lifetime of the product, which is especially important for software-intensive, connected medical devices or capital equipment.
Re-Entrant Design Controls: Managing Medical Devices That Are Never Finished Read More »
Newsletter V. 2023 Issue 2 – Making Sense of FDA’s Latest Cybersecurity Guidance for Medical Devices
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
Getting Started with the New FDA Cybersecurity Guidance
New FDA cybersecurity guidance raises the bar due to the alarming increase in cyber attacks on hospitals and healthcare technology in recent years.
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An Introduction to Medical Device Cybersecurity on the High Seas
Understanding and implementing the new FDA cybersecurity guidance. A seaworthy medical device, like a well-designed ship, requires security measures in its design, operation, and maintenance.
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Real-life Challenges of Product Teams Developing Complex Medical Devices
Presented by Voler Systems, Russ Singleton, and Aaron Joseph The challenges that product development teams and leadership face have to do with more than just technology. Complex medical devices take longer to develop, have bigger teams, and require a wider variety of expertise than developing simpler products. The panel of medical device experts share how
Real-life Challenges of Product Teams Developing Complex Medical Devices Read More »
Newsletter V. 2023 Issue 1 – Announcing Sunstone Pilot’s Adaptive Design Controls
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
Newsletter V. 2023 Issue 1 – Announcing Sunstone Pilot’s Adaptive Design Controls Read More »
Newsletter V. 2022 Issue 3
September 2022 Newsletter – Integrating Two Worlds of Product Development
Newsletter V. 2022 Issue 3 Read More »