Medical device design controls are not a separate set of activities run in parallel to product development–they are a central part of development.
Underestimating and Overestimating Design Controls 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 »
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 »
