Newsletter V. 2026 Issue 4
October2026 Newsletter – Does your quality system restrict best practices for software development?
Newsletter V. 2026 Issue 4 Read More Β»
October2026 Newsletter – Does your quality system restrict best practices for software development?
Newsletter V. 2026 Issue 4 Read More Β»
When your device has 300β¦ 3,000β¦ 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
The Shocking Scale of V&V Requirements Read More Β»
June 2026 Newsletter – AI for medical device development, compliance, regulatory, and quality operations
Newsletter V. 2026 Issue 3 Read More Β»
April 2026 – Better risk management for medical devices
Newsletter V. 2026 Issue 2 Read More Β»
February 2026 Newsletter – Practical Approaches for Risk Management and V&V
Newsletter V. 2026 Issue 1 Read More Β»
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
When should V&V really start in medical device development? Read More Β»
Happy Holidays! Wishing you and your business continued success and happiness this holiday season.
2025 Seasonβs Greetings! Read More Β»
November 2025 Newsletter – Building a firm foundation in risk management
Newsletter V. 2025 Issue 4 Read More Β»
September 2025 Newsletter – AI tools for Medical Device Development
Newsletter V. 2025 Issue 3 Read More Β»
Here are some things Iβve been working on lately that I think will be valuable to others working with medical devices. This issues includes Cybersecurity Documentations, AI for Medical Device Compliance and a Rapid Compliance with IEC 62304 Case Study.
Newsletter V. 2025 Issue 2 Read More Β»