EXPERT INSIGHTS
analyzing complex datasets and generating predictions, human oversight remains essential. Experts are needed to interpret results, validate models, and ensure ethical standards are upheld— especially when AI outputs are ambiguous or contextdependent. As healthcare becomes increasingly data-driven, this intelligent, collaborative approach ensures that every material used in medical devices is not just tested, but truly understood.
Design Verification & Validation( V & V): Automation for Safety
In the tightly regulated medical device industry, Design Verification and Validation( V & V) is critical to ensuring product safety and performance. Verification checks whether a device meets its design specifications, while validation confirms its effectiveness in real-world conditions. Regulatory bodies like the FDA and EU MDR mandate rigorous V & V processes, with standards such as FDA 21 CFR Part 820 and ISO 13485 forming the backbone of compliance.
As medical devices become more complex and software-driven, the industry is increasingly embedding V & V throughout the product lifecycle and turning to automation to enhance reliability and efficiency. Automated testing not only speeds up
development but also improves consistency and supports smoother regulatory submissions.
Modern V & V Practices Include automated testing, where AI and software tools streamline functional and non-functional testing, risk management through early identification and mitigation of potential hazards, Human Factors Engineering( HFE), which involves designing for usability to reduce operator error and cybersecurity & interoperability testing which is essential for connected devices and Software as a Medical Device( SaMD).
Despite the rise of automation, human expertise remains indispensable. Professionals are needed to define test parameters, interpret complex results, and evaluate edge cases that AI may miss. This human-AI collaboration ensures that safety benchmarks are consistently met across diverse product portfolios.
As connected health platforms and SaMD continue to grow, robust V & V frameworks are more important than ever— not just for regulatory approval, but for protecting patient health in an increasingly digital healthcare environment. Ultimately, integrating automation into V & V is not just a technological upgrade— it’ s a strategic imperative for building safer, smarter, and more resilient medical devices.
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BioVoiceNews | September 2025