STANDARDS & COMPLIANCE
I deliver ready-to-build Figma designs and design-output documentation that follow the industry, Federal and international regulations your product is audited against.
MEDICAL DEVICE
- IEC 62366 — usability engineering process for medical devices
- IEC 62304 — medical device software life-cycle
- 21 CFR Part 820 — design controls and Design History File (DHF)
- AAMI HE 75 — Human Factors guidance for display and interaction design
- ISO 13485 — medical device quality system
- FDA — 510(k) submission experience; Human Factors & usability engineering documentation
DEFENSE & MILITARY
- MIL-STD-1472H — Human Engineering Design Criteria
- DoDI 5000.02, Enclosure 7 — Human Systems Integration (HSI)
GUIDANCE
- WCAG 2.1 AA — accessible interface conformance
- Section 508 — Federal ICT accessibility alignment
- User accessibility: WCAG 2.1 "AA", ADA Title III
- Medical device: AAMI HE 75 for all display and interaction guidance
- Human Factors Engineering and ergonomics research and literature
- Interaction design recommendations from leaders like Nielsen Norman Group and IxDA
- ADA Title III — accessible public-facing design
- ISO 31030 — travel-risk design for global operations
- Federal: CFR Title 21 – Part 820, IEC 62366, IEC 62304, ISO 13485, AAMI HE 75, ISO 31030
- Industry: QSR trained, GMP, DHF controls
- Apple/Google standards: Human Interface Guidelines (HIG) & Material Design
QUALITY SYSTEMS
- QSR trained — Quality System Regulation practices
- GMP — Good Manufacturing Practice awareness
- DHF controls — traceable design output for audits
- Design documentation — screen flows and state diagrams for regulators and auditors
HOW I APPLY THEM
- Heuristic evaluation grounded in Human Factors literature
- Formative & summative usability testing with scenario-based interview guides
- Task analysis and journey mapping to define and de-risk use scenarios
- Design-output documentation formalized for submission and audit
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