Diploma in Usability Study Planning and IEC 62366 Protocols
Online postgraduate diploma of 800 hours in usability study planning and IEC 62366 protocols. 8 modules covering the usability engineering process, use specification, use-related risk analysis, user interface design, formative evaluation, summative (human factors validation) protocols, FDA human factors expectations and the usability engineering file, with an assigned technical tutor.
Diploma in Usability Study Planning and IEC 62366 Protocols — studying from Malta
Malta's healthcare system relies on public hospitals alongside a growing private sector, creating demand for engineers in medical devices, clinical technology and facilities. The Medicines Authority and the Health Directorate set regulatory expectations that shape work on medical equipment. Biomechanics and wearable technology are emerging interests, particularly in rehabilitation, sports science and occupational safety. Professionals in this area often collaborate with clinicians, distributors and regulators to ensure devices meet national and European requirements.
Fees for Malta: €895 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Malta
Typical roles
Questions from Malta
Is this programme recognised by a professional body in Malta for engineers working in health, biomechanics or wearables?
SEIUM Institute's qualifications are its own private qualifications. They are not official Maltese state degrees and are not accredited by any national body. In Malta, engineering titles are regulated through the Malta Council for Professions and the Chamber of Engineers, and medical devices fall under the Medicines Authority. Recognition of a private qualification is decided by employers or the relevant body, so check with them before enrolling.
Will employers in Malta value this training for roles in wearables or operational safety?
Employers in Malta's health technology, manufacturing and safety-related sectors decide for themselves how much weight to give a private online qualification. Many weigh practical experience and a final project heavily. SEIUM's programmes include a final project, but whether it helps your career in Malta depends on your employer's view. Speaking with prospective employers beforehand is the most reliable way to find out.
Can I study this alongside a full-time job in Malta, and is employer funding possible?
The programmes are 100% online and taught in English, so you can study from home without a student visa. Master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, so plan your weekly time accordingly. Fees are payable in instalments, and employer sponsorship is possible. Each student gets an assigned technical tutor for support.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Apply the IEC 62366-1 usability engineering process to medical devices.
Define use specifications, user groups and use environments.
Identify critical tasks and analyse use-related risk with ISO 14971.
Plan and run formative evaluations to improve the user interface.
Write summative (human factors validation) protocols and reports.
Prepare usability documentation for MDR technical files and FDA submissions.
Lead the usability engineering programme of a medical device from start to finish.
Who it's for
- Human factors and usability engineers working on medical devices.
- Medical device R&D and design engineers responsible for user interfaces.
- Quality and regulatory affairs professionals preparing usability engineering files.
- UX researchers and designers moving into regulated healthcare products.
- Risk management engineers who need to cover use errors under ISO 14971.
- Clinical specialists and nurses involved in device evaluations.
- Engineering, design or psychology graduates looking to move into the medical device sector.
What you'll work with
- IEC 62366-1 (application of usability engineering to medical devices)
- IEC TR 62366-2 (guidance on usability engineering)
- ISO 14971 (risk management for medical devices)
- IEC 60601-1-6 (usability of medical electrical equipment)
- FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (US human factors expectations)
- ANSI/AAMI HE75 (human factors engineering design guidance)
- Regulation (EU) 2017/745 (MDR), Annex I (general safety and performance requirements on use)
- ISO 9241-11 and ISO 9241-210 (usability definitions and human-centred design)
- ISO 20417 (information supplied by the manufacturer)
- Figma
- Morae or Lookback
- Tobii Pro Lab
- Microsoft Excel
- Jira
8 modules
1.1Usability, use error and use-related risk1.2Why use errors matter: incident and recall data1.3Human-centred design principles (ISO 9241-210)1.4Overview of the IEC 62366-1 process1.5User interface: hardware, software, labelling and training1.6Normal use, reasonably foreseeable misuse and abnormal use1.7Regulatory expectations in the EU and the US1.8Roles in a usability team1.9Cost and timing of usability activities1.10Exercise: usability gap analysis of a device
2.1Intended users, user profiles and user groups2.2Use environments and conditions2.3Operating principle and intended use2.4Contextual inquiry and observational research2.5Interviews and focus groups with clinicians and patients2.6Task analysis and task hierarchies2.7Known use problems from post-market data2.8Accessibility and special populations2.9Documenting the use specification2.10Exercise: use specification
3.1Linking IEC 62366-1 and ISO 149713.2Identifying hazard-related use scenarios3.3PCA analysis: perception, cognition and action3.4Use FMEA and fault tree approaches3.5Selecting critical tasks3.6Risk control measures in the user interface3.7Information for safety and labelling3.8Evaluating residual use-related risk3.9Traceability between tasks, hazards and controls3.10Exercise: use-related risk analysis
4.1User interface specification structure4.2Design guidance from ANSI/AAMI HE754.3Displays, alarms and controls4.4Software user interfaces and workflows4.5Instructions for use and quick reference guides4.6Training as part of the user interface4.7Packaging and connectors4.8Design reviews and heuristic evaluation4.9Managing user interface changes4.10Exercise: user interface specification
5.1Purpose and timing of formative evaluations5.2Choosing methods: expert review, cognitive walkthrough, usability tests5.3Participant recruitment and sample sizes5.4Prototypes and fidelity levels5.5Test environment and simulated use5.6Moderation techniques and think-aloud5.7Data collection: observation, video and eye tracking5.8Analysis of use difficulties and root causes5.9Iterating the design from formative findings5.10Exercise: formative study plan
6.1Summative evaluation (human factors validation) objectives6.2Protocol structure and content6.3Critical tasks and acceptance criteria6.4Participant groups and representative users6.5Test scenarios and realistic use conditions6.6Training decay and test sequencing6.7Data collection and root cause interviews6.8Analysis of use errors, close calls and difficulties6.9Summative report and residual risk conclusion6.10Exercise: summative test protocol
7.1FDA human factors guidance and submission content7.2Human factors engineering report structure7.3Critical task identification for FDA7.4Combination products and home-use devices7.5MDR Annex I and technical documentation7.6Usability engineering file contents7.7Post-market usability: complaints and field data7.8Usability of software and connected devices7.9Notified body and FDA review questions7.10Exercise: human factors report outline
8.1Compiling the usability engineering file8.2Traceability from use specification to validation8.3Managing changes after validation8.4Usability in design change assessments8.5Lessons learned and continuous improvement8.6Planning the integrative case and deliverables8.7Developing the case with tutor guidance8.8Verification of results and critical analysis8.9Technical defence and peer review8.10Final project: usability study plan and protocols for a medical device
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so it is compatible with full-time work.
Each module combines theory, guided reading of the reference standards and applied exercises. The working software is Figma, Morae or Lookback, Tobii Pro Lab, Microsoft Excel and Jira, in free, academic or evaluation versions. Practice is based on real usability documentation: use specifications, task analyses, use-related risk analyses, formative study reports and summative test protocols. Assessment is continuous by module, plus the final integrative project.
Standards covered: IEC 62366-1, IEC TR 62366-2, ISO 14971, IEC 60601-1-6, FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices, ANSI/AAMI HE75, Regulation (EU) 2017/745 (MDR), Annex I, ISO 9241-11 and ISO 9241-210, ISO 20417.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- An internet connection and a computer capable of running the programme software.
- English sufficient to read technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 800 hours over 6–8 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with Figma, Morae or Lookback, Tobii Pro Lab, Microsoft Excel and Jira, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the final project. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.
Yes. Modules passed are recognised in a higher programme in the same area (postgraduate diploma or master's). Ask about the recognition policy when you enrol.
Prior technical training or professional experience in the sector (no university degree is required), a computer able to run the programme software and English sufficient to read technical standards.
Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.
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