Warm Wishes from Sunstone Pilot
I’m enjoying the New England snow! Warm wishes for a happy holiday season.
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Newsletter V. 2024 Issue 3
SaMD SaMD (Software as a Medical Device) products are at the forefront of some of the most innovative new healthcare technology but present particular challenges to medical device companies. Understanding and tackling these challenges will go a long way to making your next SaMD product a success. Some of the key challenges are:Managing frequent changes
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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.
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Embracing Change: Managing Medical Devices That Are Never Finished
“Embracing Change: Managing Medical Devices That Are Never Finished” was recorded in July 2024 as part of Voler Systems’ webinar series How do we manage upgrades to a new medical device after product launch? If you don’t expect to ever make changes to the product then this may not be a concern at all. However,
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Newsletter V. 2024 Issue 2
Embracing Change: Managing Medical Devices That Are Never Finished Online webinar – July 25 Join us for a lively discussion by Aaron Joseph of how to tackle the challenges of managing software-intensive, connected medical devices; products that we want to grow and evolve after initial launch. Bring your questions on how to set up a
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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.
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Newsletter V. 2024 Issue 1 – Embracing Change for Medical Device Excellence
March 2024 – What are “re-entrant design controls” and why would a medical device company need them?
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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.
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Holiday Greetings from Boston – 2023
In 2023, I moved to Boston. While my location has changed, my dedication to outstanding service remains as strong as ever. If you need to reach me or have any questions, don’t hesitate to contact me via email or phone. I look forward to our continued collaboration. Happy Holidays – Aaron
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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