“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, […]
Embracing Change: Managing Medical Devices That Are Never Finished 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 »
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 »
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 »
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 »
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 describe some common ways that your quality system can undermine your product teams (part 1 of 2).
Using Design Controls to Undermine Medical Device Development – Part 1 Read More »
Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully
What Are Medical Device Design Controls? Read More »
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
Rules Are Changing for FDA Submissions for Software Read More »
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
Documentation for Medical Device Software Read More »
A post-mortem or retrospective is a valuable opportunity to make long-term improvements in a product development organization. Understanding the goals of a post-mortem and avoiding the 4 common pitfalls will ensure a successful and valuable outcome of the post-mortem.
Post-Mortem Pre-Celebration Read More »
