News

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 […]

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

Embracing Change: Managing Medical Devices That Are Never Finished Online webinar – July 25 Join us for a lively discussion by Aaron Joseph of how to tackle the challenges of managing software-intensive, connected medical devices; products that we want to grow and evolve after initial launch. Bring your questions on how to set up a

March 2024 – What are “re-entrant design controls” and why would a medical device company need them?

Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges

Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges

September 2022 Newsletter – Integrating Two Worlds of Product Development

September 2022 Newsletter – Integrating Two Worlds of Product Development