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2026 update · Self-paced

Human factors rules changed after 2022. Bring your work up to date.

This course is for human factors and usability engineers, regulatory affairs and quality teams who already know medical device human factors. It starts where Nopmark’s 2022 course ended and teaches only what changed at the FDA, in the international standards, in the EU, in the UK and in other key markets.

What the course covers

  1. FDAThe 2026 HF submission frameworkThe final content guidance, the 3 HF Submission Categories, the HF report, and human factors under the QMSR.
  2. FDACombination products and device-specific expectationsThe 2023 combination product Q&A, use-related risk analysis and comparative analyses for drug-led products, and device-specific FDA expectations.
  3. AIHuman-AI interactionTransparency, automation bias and human oversight from FDA, IMDRF and the EU AI Act, and machine learning hazards in the use-related risk analysis.
  4. StandardsWhat changed and what did notANSI/AAMI HE75:2025, the status of IEC 62366, ISO 14971 and IEC 60601, and labeling and symbol references such as ISO 20417:2026.
  5. EUMDR usability evidenceThe MDR usability file, electronic IFU rules, and use errors in vigilance and PSURs.
  6. UKMHRA guidance and post-market rulesThe current MHRA guidance, GB designated standards, the new GB post-market rules, and GB market access and AI policy.
  7. Other marketsJapan, China, Canada, Australia and moreThe Japanese and Chinese usability requirements, other national changes and a watch list.
  8. All marketsOne HF evidence plan for many marketsAn exercise with a worked solution: plan one evidence set for a device sold in several markets.
Chapters
8
Video lessons
26, about 15 min each
Exercises
2, with worked solutions
Running case
NX-2 infusion pump

You need a working knowledge of medical device human factors and usability engineering. This course does not teach the basics again.

What you can do after the course

  • Size the human factors content of each FDA submission. Pick the HF Submission Category from FDA’s final 2026 content guidance and include the report sections that FDA recommends for it.
  • Update your procedures and templates. Replace references to 21 CFR 820.30, the removed report outline in Appendix A of the 2016 HF guidance, and older standard editions with what applies now.
  • Plan human factors for AI-enabled features. Address transparency, automation bias and human oversight as FDA, IMDRF and the EU AI Act describe them.
  • Reuse one evidence set across markets. See what the US, EU, UK, Japan, China, Canada and Australia ask for, and where a market needs something extra.
A lesson frame. It shows the August 3, 2026 edition of the FDA guidance Applying Human Factors and Usability Engineering to Medical Devices, the guidance history note that deleted Appendix A, and a list of 5 other changes, such as Heuristic Analysis renamed to Heuristic Evaluation.

From the lesson on the 2026 FDA human factors guidance set.

Each lesson starts from what you already know.

  1. The 2022 pointA short recap of what the 2022 course taught.
  2. What changedThe new or revised text, with its date and the page of the primary source.
  3. What you do nowThe change applied to one fictional device, the NX-2 infusion pump.

Drafts and proposals are taught as items to watch, not as requirements.

Course curriculum

    1. VID-1.1.1-01 Map the 2026 FDA human factors guidance set

    2. VID-1.1.2-01 Walk the FDA decision points A to D

    3. VID-1.1.2-02 Pick the category in the FDA examples

    4. Activity: Pick the FDA HF Submission Category

    5. Solution: Pick the FDA HF Submission Category

    6. VID-1.1.3-01 Write the HF report for each category

    7. VID-1.2.1-01 Find human factors in the QMSR

    1. VID-2.1.1-01 Apply HF principles to combination products

    2. VID-2.1.2-01 Use the URRA and comparative analyses for drug-led products

    3. VID-2.2.1-01 Meet device-specific FDA HF expectations

    1. VID-3.1.1-01 Design for the human-AI team

    2. VID-3.2.1-01 Evaluate usability of AI-enabled device software2.1-01

    3. VID-3.2.2-01 Keep AI usability evidence current as the device changes

    4. VID-3.3.1-01 Design for human oversight under the EU AI Act

    5. VID-3.4.1-01 Add machine learning hazards to the use-related risk analysis

    1. VID-4.1.1-01 Update your design references to HE752025

    2. VID-4.1.2-01 Know the status of IEC 62366, ISO 14971 and IEC 60601

    3. VID-4.1.3-01 Update labeling, symbol and accessibility references

    1. VID-5.1.1-01 Build the MDR usability file without a harmonised EN 62366-1

    2. VID-5.1.2-01 Plan and validate an EU electronic IFU

    3. VID-5.2.1-01 Handle use errors in EU vigilance and PSURs

    1. VID-6.1.1-01 Apply the GB HF guidance, designated standards and PMS rules

    2. VID-6.1.2-01 Track GB market access and AI policy for HF

About this course

  • $249.00
  • 30 lessons
  • 6.5 hours of video content