Last modified: 18-NOV-2024 Software as a Medical Device (SaMD) products do not involve hardware or manufacturing but their documentation is still complicated and it can be difficult to know what is truly required for compliance. To help reduce the confusion, I created this SaMD Documentation Map which illustrates the formal documentation needed for a typical […]
SaMD Documentation Map Read More »
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 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 »
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 »
