Agile medical device development can provide tremendous benefits but agile methods must be modified for successful hardware development and regulatory compliance. The MAHD Framework provides a proven process with these modifications.
Secrets to Unlocking Agile Benefits for Medical Device Development Read More »
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 »
Topic: Time to rethink developing software-intensive medical devices Understanding medical device software compliance starts with processes Accelerated change management with The Hub Managing product data in a platform (The Hub) enabled the product team to rapidly respond to unexpected design changes at the worst time (in the middle of V&V) while still generating rigorously controlled
Newsletter V. 2025 Issue 1 Read More »
Understanding all of the types of software at a medical device company is crucial to knowing what is required for validating, documenting, and controlling each type
Understanding the Software Landscape Read More »
Here’s a secret about understanding medical device software documentation: don’t start with a checklist of documents! Instead, start by understanding the processes necessary for compliance and the activities in those processes.
Secrets to Medical Device Software Documentation Read More »
