The Human Factor: A Practical Guide to IEC 62366-1 Usability Engineering
Medical Device Global Market Access · Pure Global
August 3, 20253m 21s
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Show Notes
This episode demystifies the globally recognized standard IEC 62366-1:2015, which governs the application of usability engineering to medical devices. We explore how this process-oriented standard is critical not just for user satisfaction, but for ensuring patient safety by minimizing use-related risks. Learn about the key phases, from defining use specifications and conducting formative evaluations to performing final summative validation, all of which are essential for securing market access in key regions like the US and EU.
• What is usability engineering and why is it about safety, not just user-friendliness?
• How does IEC 62366-1:2015 integrate with the ISO 14971 risk management process?
• What is the critical difference between formative and summative evaluations?
• Why is a Usability Engineering File a required component of your regulatory submission?
• How can non-compliance with this standard block your device from global markets?
• What are "hazard-related use scenarios" and why are they vital for testing?
• How do you properly define user profiles and use environments?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.