Newsletter V. 2022 Issue 3
September 2022 Newsletter – Integrating Two Worlds of Product Development
Using Design Controls to Undermine Medical Device Development – Part 2
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)
Newsletter V. 2022 Issue 2
September 2022 Newsletter – Integrating Two Worlds of Product Development
Using Design Controls to Undermine Medical Device Development – Part 1
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).
Newsletter V. 2022 Issue 1
March 2022 Newsletter – Back to Basics with Design Controls. Changes are coming to design control regulations. Advanced design controls
What Are Medical Device Design Controls?
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 …
Documentation for Medical Device Software
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.
Accelerating Value Delivery for Medical Device Software
Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
Intro to SaMD
SaMD, or Software as a Medical Device, is not just another mobile app. It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.
Get a Grip on Medical Device Development
Or the 5 Types of Knowledge needed for successful Medical Device development Developing innovative new products is hard but developing innovative new medical devices is even harder. That’s because while both involve a great deal of knowledge, medical device development requires even more knowledge and across a broader range of domains. Some engineers assume …