Integrating Human Factors into the Quality System (QMS)

Human factors isn’t a “nice-to-have” add-on—it’s one of the most powerful ways to reduce use errors, prevent recurring CAPAs, and build safer, more intuitive medical devices.

In this Friday In-Focus session, a panel of human factors and MedTech safety leaders explores how human factors should be embedded early and throughout the QMS, showing up clearly in design controls, risk management, usability engineering, and even IFU development.

You’ll hear practical examples of how teams can stop treating usability issues as “training problems” and instead fix the root cause—the design. From use-related risk analysis (URA) pitfalls to real-world user behavior engineers don’t anticipate, this discussion offers actionable guidance for RA/QA, engineering, and product teams who want a QMS that actually prevents harm.

⭐ What You’ll Learn
• Where human factors hides inside your QMS (CAPAs, IFU rewrites, recurring errors).
• Why “train the user” is often the wrong solution—and what to do instead
• How URA quality breaks down (inconsistent severity ratings, weak hazard descriptions, no access to product experts).
• How to build strong use-related risk controls using cross-functional collaboration.
• Why formative testing must happen before design controls lock requirements.
• How to design IFUs that users actually follow (readability, visuals, QRGs, warning emphasis).
• Why human factors is central to patient safety risk (often bigger than “design or software failures”).

⏱️ Chapters (Clean)
00:00 – Welcome & context: why human factors must be integrated into QMS
01:58 – Resource callout: request the “prep kit” for MedTech usability support
06:57 – Real example: recurring errors stopped by fixing design flaws (not training users)
09:12 – Why human factors is a leading driver of patient safety risk
10:50 – Human factors in risk management: tailoring to stakeholder context
20:18 – Human factors missing from the core team: what changed once added
23:07 – Engineers make “rational but wrong” decisions without clinical context
28:35 – URA mistakes: inconsistent severity ratings & poor hazard descriptions
30:05 – URAs written without product access: why that causes weak task analysis
35:04 – IFU optimization: what users preferred (font, color coding, symbols)
37:00 – Off-label use vs “abnormal use”: what must flow into risk management
40:14 – Formative vs summative testing: why timing matters (cost and rework)
41:30 – Resource callout: request the “seven point assessment”
42:00 – Resource callout: request slides & usability materials from Clarimed
43:35 – Capturing all user groups in requirements (not just primary users)
45:10 – Case example: designing for distinct user populations (migraine vs cluster)
48:34 – Missed hazard example: safety cap mistake & URA-driven mitigation
51:00 – Why engineers can’t predict user behavior (HF closes risk blind spots)
51:40 – Combination products: risks from users transferring habits between devices
53:45 – Why investing in usability testing prevents expensive downstream issues
57:16 – IFUs that work: visuals, flow, and accessibility for real-world use
57:20 – IFU readability guidance: OTC vs professional reading levels
58:45 – Quick Reference Guides (QRGs): why they reduce cognitive load
58:52 – HF in design controls: critical tasks, environments, limitations → testable requirements
01:00:25 – Resource callout: request the slide deck (“slides”)
01:00:40 – How to get the prep kit / materials / guidance after the session
01:01:30 – Resource callout: request “guidance” for personalized support
01:01:44 – Upcoming sessions announced (EU MDR revisions + lead auditor training)
01:03:00 – Closing: why live collaboration strengthens the MedTech community

ℹ️ About Friday In-Focus
Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers.

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