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𝑺𝒄𝒂𝒍𝒆 𝒐𝒇 𝑽&𝑽 π‘Ήπ’†π’’π’–π’Šπ’“π’†π’Žπ’†π’π’•π’”

The Shocking Scale of V&V Requirements

When your device has 300… 3,000… or 12,000 requirements β€” Verification & Validation has reached an entirely new scale. In this clip, Aaron Joseph talks about one of the most critical (and often underestimated) elements of medical device development: traceability.  In highly complex systems like surgical robotics, without clear requirement-to-test traceability, even great engineering looks […]

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Development Stages

When should V&V really start in medical device development?

V&V is traditionally viewed as the final phase of medical device development, but successful teams begin preparing for it from the start. While formal, documented Verification & Validation occurs at the end to demonstrate compliance, effective development integrates testing throughout. This includes developing test methods, building tools, and evaluating prototypes early and often. Waiting until

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Sunstone Pilot NewsletterHeader

Newsletter V. 2025 Issue 1

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

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