Postgraduate Diploma in Usability (IEC 62366) and Cyber in SaMD
Online 800-hour Postgraduate Diploma in usability (IEC 62366) and cyber in SaMD. 8 modules covering IEC 62366-1, IEC 81001-5-1 and Figma. Assigned tutor and enrolment open.
Postgraduate Diploma in Usability (IEC 62366) and Cyber in SaMD — studying from Malta
Malta has a well-developed telecommunications sector, with a history of hosting submarine cable landing points and a substantial base of network and communications providers. The island's regulatory environment supports digital infrastructure, and this has encouraged companies in embedded systems, network engineering and electronics design. Employers include telecommunications operators, software and hardware developers, and multinational technology firms with Maltese engineering teams. Engineers with knowledge of wireless systems, network security and embedded programming find steady demand.
Fees for Malta: €1,290 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Malta
Typical roles
Questions from Malta
How are electronics and telecom engineers recognised professionally in Malta?
Engineering titles in Malta are regulated by the Chamber of Engineers (KSU) under the Engineering Profession Act. Telecommunications is overseen by the Malta Communications Authority, which regulates licensing and spectrum. A SEIUM qualification is a private one, not a state degree and not accredited by a national body, so recognition depends on employers and the relevant authority.
Which Maltese employers hire embedded systems and telecom engineers?
Malta has telecoms operators, electronics manufacturers and component suppliers, iGaming and technology firms that use embedded hardware, and defence and maritime electronics companies. Employers typically assess hands-on design experience and certifications. A private qualification can help your profile, especially alongside practical projects.
Can I fit this programme around work, and what are the practical requirements?
The programme is 100% online and taught in English, with an assigned technical tutor. You can study from Malta without a student visa. Choose a course length that matches your available time, from 300 hours up to 1,900. Ask about fee instalments and employer sponsorship before enrolling.
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
Classify software as a medical device under the MDR.
Apply the usability engineering process of IEC 62366-1.
Plan formative evaluations and summative validations.
Design interfaces that prevent hazardous use errors.
Model threats and apply IEC 81001-5-1 to SaMD.
Manage vulnerabilities during post-market surveillance.
Document usability and cybersecurity for certification.
Who it's for
- Human factors engineer who wants to specialise in Usability (IEC 62366) and Cyber in SaMD.
- UX designer of medical devices who wants to specialise in Usability (IEC 62366) and Cyber in SaMD.
- Product cybersecurity engineer who wants to specialise in Usability (IEC 62366) and Cyber in SaMD.
- Regulatory affairs specialist who wants to specialise in Usability (IEC 62366) and Cyber in SaMD.
- Medical software developer who wants to specialise in Usability (IEC 62366) and Cyber in SaMD.
- Software quality engineer who wants to specialise in Usability (IEC 62366) and Cyber in SaMD.
- Graduates in engineering or science who want to enter the medical device sector.
What you'll work with
- IEC 62366-1
- IEC 81001-5-1
- IEC 62304
- ISO 14971
- MDCG 2019-16
- IEC/TR 62366-2
- AAMI TIR57
- IEC 82304-1
8 modules · 800 h
1.1Definition of SaMD according to IMDRF1.2Classification under MDR Rule 111.3IMDRF risk categorisation framework1.4Software in a device versus SaMD1.5Mobile applications and web platforms1.6Software with artificial intelligence1.7IEC 62304 lifecycle applied to SaMD1.8Health software safety IEC 82304-11.9Software surveillance obligations1.10Case study: classification of a diagnostic app
2.1Usability engineering process2.2Intended use specification2.3User profiles and use environments2.4User interface and its elements2.5Hazardous use scenarios2.6Critical tasks2.7Relationship with ISO 149712.8Usability engineering file2.9User interface of unknown origin2.10Workshop: intended use specification for a SaMD
3.1Formative evaluation methods3.2Heuristic evaluation and cognitive walkthrough3.3Prototyping and early testing3.4Summative study design3.5Selecting representative participants3.6Analysis of use errors3.7Root cause of difficulties3.8FDA human factors guidance3.9Usability validation report3.10Practice: summative test protocol
4.1User-centred design principles4.2Error prevention and tolerance4.3Presentation of clinical data4.4Alarms and notifications4.5Accessibility and WCAG4.6Electronic labelling and instructions4.7Artificial intelligence interfaces and explainability4.8Localisation and languages4.9Consistency across platforms4.10Laboratory: redesign of a critical screen
5.1MDCG 2019-16 guidance5.2Software security IEC 81001-5-15.3STRIDE threat modelling5.4Security risk according to AAMI TIR575.5Secure architecture and defence in depth5.6Authentication, authorisation and sessions5.7Health data protection and GDPR5.8SBOM and third-party component management5.9FDA premarket cybersecurity guidance5.10Workshop: threat model of a clinical app
6.1Static security analysis6.2Dynamic testing and vulnerability scanning6.3Authorised penetration testing6.4Post-market vulnerability management6.5Coordinated disclosure6.6Secure patches and updates6.7Security event monitoring6.8Incident response for medical devices6.9Interaction between security and usability6.10Practice: vulnerability scanning with OWASP ZAP
7.1Technical usability documentation7.2Cybersecurity documentation7.3Risk-requirement-test traceability7.4Notified body review7.5FDA submission requirements7.6Safety information for users7.7Software change management7.8Audits of development processes7.9Lessons from software recalls7.10Case study: review of a SaMD technical file
8.1SaMD description and intended use8.2Intended use specification and critical tasks8.3Formative evaluation8.4Summative validation protocol8.5Threat model8.6Proposed security controls8.7Post-market maintenance plan8.8Traceability matrix8.9Report and presentation8.10Final review with the tutor
How you'll learn
A 100% online programme 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 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, Dovetail, OWASP ZAP, Microsoft Threat Modeling Tool, Snyk, in free, academic or evaluation versions. Tests are studied using real summative usability test procedures with users, threat modelling of a clinical application and authorised vulnerability scanning. Assessment is continuous across each module, plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Classify software as a medical device under the MDR.
Apply the usability engineering process of IEC 62366-1.
Plan formative evaluations and summative validations.
Design interfaces that prevent hazardous use errors.
Model threats and apply IEC 81001-5-1 to SaMD.
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 English to follow technical regulatory reading.
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 between 10 and 15 hours per week on average, compatible with a full-time job.
You will work with Figma, Dovetail, OWASP ZAP, Microsoft Threat Modeling Tool, Snyk. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
A SEIUM own diploma upon passing the continuous assessment and the integrating project. It is in-house training, not an official title from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area are credited towards the advanced programme. Check the recognition policy when you enrol.
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