Both HFE and UE are based on the international usability standards IEC 62366-1 and IEC 62366-2 with consideration of risk management (ISO 14971). By planning and integrating usability testing for human interaction with medical device technology throughout the device lifecycle and risk management processes, HFE/UE ensures that medical devices meet the complex needs of healthcare professionals and patients, and that user-related and use-related risks are eliminated or mitigated.

Our expert writes: Historically, medical device companies have provided value by producing equipment for diagnosing and treating patients worldwide. However, contemporary challenges such as heightened pricing pressures, regulatory compliance, supply chain volatility and operational inefficiencies have significantly changed the landscape for these companies.

The integration of AI in biopharma workflows is not just a technological advancement, but a paradigm shift that promises to completely revolutionize how we research, understand, and treat diseases. Read what this expert has to say.