Postgraduate Diploma in Formative and Summative Assessments
Online 800-hour Postgraduate Diploma in Formative and Summative Assessments. 8 modules covering IEC 62366-1 (usability engineering for medical devices), IEC/TR 62366-2 and Tobii Pro Lab. Assigned tutor and open enrolment.
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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
Describe the usability engineering process according to IEC 62366-1.
Plan formative assessments throughout the design process.
Define users, environments and critical tasks for studies.
Moderate sessions and collect qualitative and quantitative data.
Design and carry out a summative validation.
Analyse use errors and root causes in the results.
Adapt assessments to special cases such as home use or combination products.
Who it's for
- Medical device usability engineer seeking to specialise in Formative and Summative Assessments.
- Human factors specialist seeking to specialise in Formative and Summative Assessments.
- UX researcher in healthcare seeking to specialise in Formative and Summative Assessments.
- Moderator of usability studies seeking to specialise in Formative and Summative Assessments.
- Usability documentation manager seeking to specialise in Formative and Summative Assessments.
- Regulatory consultant in human factors seeking to specialise in Formative and Summative Assessments.
- Engineering or science graduates looking to enter medical device manufacturers.
What you'll work with
- IEC 62366-1 (usability engineering for medical devices)
- IEC/TR 62366-2
- FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (2016)
- ANSI/AAMI HE75 (human factors engineering)
- IEC 60601-1-6 (usability of electromedical equipment)
- ISO 9241-11 (usability, definitions)
8 modules · 800 h
1.1IEC 62366-1 and the usability engineering process1.2FDA human factors guidance of 20161.3Intended users, intended use and environment1.4Use specification1.5User interface and its elements1.6Critical tasks and use scenarios1.7Relationship with risk management1.8Usability engineering file1.9Human factors report for the FDA1.10Case study: use specification of an auto-injector
2.1Objectives of formative assessment2.2Moments in the design cycle2.3Early contextual inquiry2.4Expert heuristic evaluation2.5Cognitive walkthrough2.6Formative tests with prototypes2.7Small samples and iteration2.8Recording difficulties and close calls2.9Translating findings into requirements2.10Practice: heuristic evaluation of a glucose meter
3.1Assessment protocols3.2Selection of tasks and scenarios3.3User profiles and groups3.4Sample size and justification3.5Participant recruitment3.6Simulated environment and realism3.7Prior training and washout period3.8Moderator and observers3.9Consent and ethics3.10Workshop: protocol for a formative study
4.1Session moderation4.2Observation of use errors4.3Think-aloud protocol4.4Post-task interview4.5Video recording and coding4.6Performance and time measures4.7Satisfaction questionnaires4.8Managing incidents during sessions4.9Remote studies4.10Laboratory: moderated session with an inhaler prototype
5.1User interface validation5.2Acceptance criteria5.3Representativeness of users: minimum of 15 per group5.4Representative production of the device5.5Instructions for use and training5.6Critical tasks and knowledge5.7Labelling assessment5.8Differences between FDA and MDR5.9Summative assessments in clinical studies5.10Practice: summative validation plan
6.1Root cause analysis of use errors6.2Classification of errors, close calls and difficulties6.3Qualitative analysis of interviews6.4Determining residual risk6.5Decisions on design modifications6.6Justification of unmitigated risks6.7Writing the study report6.8Traceability with risk analysis6.9Presentation to regulators6.10Case study: error analysis in a summative study
7.1Home-use devices7.2Lay users and patients7.3Drug-device combination products7.4Medical software and mobile applications7.5Alarm interfaces7.6Paediatric and elderly users7.7Connected products7.8Changes to marketed devices7.9International assessments7.10Workshop: adapting a study for a medical app
8.1Device selection8.2Use specification8.3Critical task analysis8.4Formative assessment8.5Design iteration8.6Summative protocol8.7Analysis of results8.8Usability engineering report8.9Dissertation and presentation8.10Final review with the tutor
How you'll learn
Fully 100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the enrolment period, which makes it possible to combine the programme with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Tobii Pro Lab, Lookback, Dovetail, IBM SPSS Statistics, in free, academic or evaluation versions. Tests are studied using real usability laboratory procedures, trials in a simulated use environment and summative validation studies with representative users. Assessment is continuous by module, plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe the usability engineering process according to IEC 62366-1.
Plan formative assessments throughout the design process.
Define users, environments and critical tasks for studies.
Moderate sessions and collect qualitative and quantitative data.
Design and carry out a summative validation.
Where this takes you
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 level of 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.
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 Tobii Pro Lab, Lookback, Dovetail, IBM SPSS Statistics. Free, academic or evaluation versions are used, and the tutor indicates a free alternative where one exists.
A SEIUM own diploma upon passing continuous assessment and the integrative project. It is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher-level programme. Check the recognition policy when you enrol.
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