March 2024 – What are “re-entrant design controls” and why would a medical device company need them?
Newsletter V. 2024 Issue 1 – Embracing Change for Medical Device Excellence Read More »
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 »
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
Holiday Greetings from Boston – 2023 Read More »
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
New FDA cybersecurity guidance raises the bar due to the alarming increase in cyber attacks on hospitals and healthcare technology in recent years.
Getting Started with the New FDA Cybersecurity Guidance Read More »
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.
An Introduction to Medical Device Cybersecurity on the High Seas Read More »
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 »
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 »
September 2022 Newsletter – Integrating Two Worlds of Product Development
Newsletter V. 2022 Issue 3 Read More »
Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I continue the list of ways that your quality system can undermine your product teams (part 2 of 2)
Using Design Controls to Undermine Medical Device Development – Part 2 Read More »
