Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Postgraduate Diploma in Patient/Clinician-Centred Design and Heuristics

Online 800-hour Postgraduate Diploma in Patient/Clinician-Centred Design and Heuristics. 8 modules covering IEC 62366-1 (usability engineering for medical devices), IEC/TR 62366-2 (usability application guidance) and Figma. Assigned tutor and open enrolment.

Duration800 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma

Postgraduate Diploma in Patient/Clinician-Centred Design and Heuristics — studying from Ireland

Ireland is a significant centre for medical technology and pharmaceuticals, with many international device manufacturers and a strong cluster of biomedical research in Galway, Limerick and Dublin. Biomechanics, wearable sensing and occupational health technologies are developed by companies, hospitals and research institutes such as the National University of Ireland Galway's research groups. Engineers in this area design medical devices, rehabilitation systems and safety monitoring solutions under strict regulatory requirements. Oversight comes from the Health Products Regulatory Authority and the Health and Safety Authority.

Fees for Ireland: €895 (Euro), with instalments and employer sponsorship available.

Relevant bodies in Ireland

  • Health Products Regulatory Authority (HPRA)
  • Health and Safety Authority (HSA)
  • Irish Medtech Association (IMTA)
  • Engineers Ireland

Typical roles

  • Biomedical Engineer
  • Medical Device Engineer
  • Biomechanics Engineer
  • Wearables Systems Engineer

Questions from Ireland

Will this qualification be recognised by professional bodies in Ireland for this area?

SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body. Recognition is decided by individual employers or the relevant body. In Ireland, engineers in this field may look to Engineers Ireland for professional membership, but completing a SEIUM programme does not by itself grant membership of any body. Check requirements directly with the body concerned before enrolling.

How might this training be used by employers in Ireland working in this area?

Employers in Ireland decide for themselves how much weight to give a private online qualification. Many assess it alongside your existing experience, the final project and your portfolio. Roles in medical devices, occupational health and workplace safety may value specialist knowledge, but there is no guarantee of recognition or of any salary or promotion outcome. Ask prospective employers whether they would accept the qualification.

Can I study this alongside a full-time job, and does my employer need to fund it?

Programmes are fully online and taught in English, so you can study from home at your own pace around work. Master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, so plan your weekly commitment accordingly. Fees can be paid in instalments, and employer sponsorship is possible if your company agrees. Each student is assigned a technical tutor for support.

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Learning outcomes

What you will be able to do

01

Apply the usability engineering process of IEC 62366-1.

02

Plan user research with patients and clinical professionals.

03

Carry out heuristic evaluations and cognitive walkthroughs.

04

Design clinical interfaces that reduce use errors.

05

Prototype and run iterative formative evaluations.

06

Design and document a summative validation.

07

Maintain usability throughout the product lifecycle.

Profile

Who it's for

  • Healthcare usability engineer wishing to specialise in Patient/Clinician-Centred Design and Heuristics.
  • Clinical software UX designer wishing to specialise in Patient/Clinician-Centred Design and Heuristics.
  • Human factors specialist wishing to specialise in Patient/Clinician-Centred Design and Heuristics.
  • User researcher wishing to specialise in Patient/Clinician-Centred Design and Heuristics.
  • Medical device interface designer wishing to specialise in Patient/Clinician-Centred Design and Heuristics.
  • Summative validation consultant wishing to specialise in Patient/Clinician-Centred Design and Heuristics.
  • Graduates in engineering or sciences seeking to enter health technology.
Standards & tools

What you'll work with

  • IEC 62366-1 (usability engineering for medical devices)
  • IEC/TR 62366-2 (usability application guidance)
  • IEC 60601-1-6 (usability of medical electrical equipment)
  • ANSI/AAMI HE75 (human factors engineering)
  • ISO 9241-210 (user-centred design)
  • ISO 9241-110 (interaction principles)
  • FDA guidance on human factors and usability engineering (2016)
Syllabus

8 modules · 800 h

  1. 1.1Human factors in health technology
  2. 1.2Use errors and adverse events
  3. 1.3Users: patients, carers and clinicians
  4. 1.4Use environments: hospital, home and ambulance
  5. 1.5The IEC 62366-1 process
  6. 1.6Intended use specification and user profiles
  7. 1.7Critical tasks and hazard scenarios
  8. 1.8Relationship with ISO 14971 risk management
  9. 1.9FDA human factors guidance
  10. 1.10Case study: analysis of an infusion pump programming error
  1. 2.1Contextual interviews on the ward
  2. 2.2Observation of clinical workflows
  3. 2.3Patient journey maps
  4. 2.4Personas and scenarios
  5. 2.5Hierarchical task analysis
  6. 2.6Workload and interruptions
  7. 2.7Health and digital literacy
  8. 2.8Accessibility and reduced capabilities
  9. 2.9Synthesis of findings
  10. 2.10Practice: task analysis of a blood glucose meter
  1. 3.1Nielsen's heuristics
  2. 3.2Zhang's heuristics for medical devices
  3. 3.3Cognitive walkthrough
  4. 3.4PCA analysis of perception, cognition and action
  5. 3.5Problem severity classification
  6. 3.6Evaluation of labelling and instructions
  7. 3.7Review of alarms and alerts
  8. 3.8Consistency between devices in the environment
  9. 3.9Heuristic evaluation report
  10. 3.10Workshop: heuristic evaluation of a vital signs monitor
  1. 4.1Information architecture for clinicians
  2. 4.2Visualisation of physiological data
  3. 4.3Form design and dose entry
  4. 4.4Error prevention and confirmations
  5. 4.5Touchscreens used with gloves
  6. 4.6Interface design for older patients
  7. 4.7Plain language and ISO 15223-1 pictograms
  8. 4.8Home interfaces and remote monitoring
  9. 4.9Design systems for healthcare software
  10. 4.10Practice: prescription screen prototype
  1. 5.1Low- and high-fidelity prototypes
  2. 5.2Clinical simulation to evaluate designs
  3. 5.3Formative usability tests
  4. 5.4Think-aloud
  5. 5.5Metrics: effectiveness, efficiency and satisfaction
  6. 5.6SUS and NASA-TLX scales
  7. 5.7Participant sampling
  8. 5.8Root cause analysis of use errors
  9. 5.9Design iteration
  10. 5.10Laboratory: formative test with five users
  1. 6.1Purpose of the summative evaluation
  2. 6.2Protocol and critical tasks
  3. 6.3Sample size per user group
  4. 6.4Prior training and representative environment
  5. 6.5Data collection and video
  6. 6.6Classification of errors and difficulties
  7. 6.7Residual risk analysis
  8. 6.8Usability engineering report
  9. 6.9FDA and MDR requirements
  10. 6.10Case study: summative validation plan for an auto-injector
  1. 7.1Integration with design controls
  2. 7.2Usability of clinical AI software
  3. 7.3Post-market surveillance and use complaints
  4. 7.4Design changes and re-evaluation
  5. 7.5Usability in high-pressure environments
  6. 7.6Inclusive design and equity
  7. 7.7Document management of the usability file
  8. 7.8Training design teams
  9. 7.9Notified body audits
  10. 7.10Practice: complaint review to detect use errors
  1. 8.1Device selection and context
  2. 8.2User research
  3. 8.3Critical task analysis
  4. 8.4Heuristic evaluation
  5. 8.5Interface redesign
  6. 8.6Formative test
  7. 8.7Summative validation plan
  8. 8.8Usability engineering file
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

How you'll learn

Fully 100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetable: students progress at their own pace within the intake, which makes it possible to combine study with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Figma, Axure RP, Tobii Pro Lab, Lookback, Optimal Workshop, in free, academic or evaluation versions. Tests are studied using real usability laboratory procedures with a simulated clinical environment, heuristic evaluations with experts, and formative and summative tests with representative users. Assessment is continuous per module plus the final integrative project.

Accredited laboratories(EN ISO/IEC 17025) with a rotor test bench, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-oriented Master's Thesis:safety case, test plan, compliance dossier and operating limits.
Industry-led mentoring:teaching staff with experience in formation flying, , eVTOL/UAM and flight test.
Flexible delivery(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:a safety-by-design approach, with cyber-OT, DIH and compliance as its pillars.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Device selection and context

Apply the usability engineering process of IEC 62366-1.

User research

Plan user research with patients and clinical professionals.

Critical task analysis

Carry out heuristic evaluations and cognitive walkthroughs.

Heuristic evaluation

Design clinical interfaces that reduce use errors.

Interface redesign

Prototype and run iterative formative evaluations.

Career opportunities

Where this takes you

Healthcare usability engineerClinical software UX designerHuman factors specialistUser researcherMedical device interface designerSummative validation consultant
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • Internet connection and a computer capable of running the programme's software.
  • Sufficient Spanish to follow technical regulatory texts.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

FAQ

Frequently asked questions

The programme totals 800 hours spread over 6 to 8 months. That is an average of 10 to 15 hours per week, compatible with a full-time job.

You will work with Figma, Axure RP, Tobii Pro Lab, Lookback, Optimal Workshop. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.

An in-house diploma from SEIUM upon passing the continuous assessment and the integrative project. It is in-house training, not an official Ministry qualification.

Yes. Modules passed on a course or diploma in the same area can be recognised towards the advanced programme. Check the recognition policy when you enrol.

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