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 »
CLIENT Small Medical Startup (<10 employees) Company Stage: Developing digital health product (SaMD) CHALLENGES Client staff consisted of physicians and engineers who had no experience with medical devices and regulations Aggressive timeline for software development, testing, and FDA submission No quality system and no head of quality SOLUTION Used a staged implementation for quality system
Starting Up Design Controls for SaMD 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 »
Training for xxx OUTLINE Module 1 Below is the video for Module 1 … Module 2 Quiz Test your understanding of the material covered in Modules 1-n.
Video sequence MOCKUP Read More »
I’m enjoying the New England snow! Warm wishes for a happy holiday season.
Warm Wishes from Sunstone Pilot Read More »
SaMD SaMD (Software as a Medical Device) products are at the forefront of some of the most innovative new healthcare technology but present particular challenges to medical device companies. Understanding and tackling these challenges will go a long way to making your next SaMD product a success. Some of the key challenges are:Managing frequent changes
Newsletter V. 2024 Issue 3 Read More »
This SaMD Documentation Map illustrates the formal documentation needed for a typical Software as a Medical Device (SaMD) product. The map is a graphical representation of the interdependencies of the product documentation and what is needed for an FDA 510(k) submission.
SaMD Documentation Map Read More »
“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 »
