Postgraduate Diploma in ISO 14971 Risk Management and Regulated Usability
Online 800-hour Postgraduate Diploma in ISO 14971 Risk Management and Regulated Usability. 8 modules covering ISO 14971 (risk management for medical devices), IEC 62366-1 (usability engineering) and Greenlight Guru. Assigned tutor and open enrolment.
Postgraduate Diploma in ISO 14971 Risk Management and Regulated Usability — 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 ISO 14971 risk management process.
Carry out risk analyses using techniques such as FMEA and FTA.
Evaluate risks and define control measures.
Apply regulated usability engineering.
Integrate usability analysis into the risk file.
Manage production and post-market information.
Prepare regulatory compliance audits.
Who it's for
- Risk management engineer who wants to specialise in ISO 14971 Risk Management and Regulated Usability.
- Regulatory affairs specialist who wants to specialise in ISO 14971 Risk Management and Regulated Usability.
- Medical device quality manager who wants to specialise in ISO 14971 Risk Management and Regulated Usability.
- ISO 13485 auditor who wants to specialise in ISO 14971 Risk Management and Regulated Usability.
- Usability engineer who wants to specialise in ISO 14971 Risk Management and Regulated Usability.
- Vigilance and post-market surveillance technician who wants to specialise in ISO 14971 Risk Management and Regulated Usability.
- Engineering or science graduates looking to enter medical device manufacturers.
What you'll work with
- ISO 14971 (risk management for medical devices)
- IEC 62366-1 (usability engineering)
- ISO 13485 (quality management systems for medical devices)
- ISO/TR 24971
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- MDSAP (Medical Device Single Audit Program)
8 modules · 800 h
1.1ISO 14971:2019 standard1.2ISO/TR 24971 technical report1.3MDR Annex I safety requirements1.4Definitions: hazard, hazardous situation and harm1.5Risk acceptability policy1.6Risk management plan1.7Risk management file1.8Management responsibilities1.9Integration with ISO 134851.10Case study: risk management plan for a monitor
2.1Intended use and foreseeable misuse2.2Safety-related characteristics2.3Hazard identification2.4Sequences of events2.5Techniques: PHA, FMEA and FTA2.6Software risk analysis2.7Biocompatibility and electrical hazards2.8Estimation of severity and probability2.9Probability P1 and P22.10Practice: design FMEA of a device
3.1Risk matrix and criteria3.2Control options according to the hierarchy3.3Verification of control measures3.4Risks arising from control measures3.5Integrity of risk control3.6Individual residual risk3.7Overall residual risk3.8Benefit-risk analysis3.9Safety information for the user3.10Workshop: risk control table with traceability
4.1IEC 62366-1 process4.2Use specification4.3Safety-related interface characteristics4.4Hazardous use scenarios4.5Selection for summative evaluation4.6Interface evaluation plan4.7FDA human factors guidance requirements4.8User interfaces of unknown origin4.9Usability engineering file4.10Case study: hazardous use scenarios of a defibrillator
5.1Link between risk file and usability5.2Use errors as a cause of hazard5.3Interface design control measures5.4Labelling as a control measure5.5Validation of usability measures5.6Residual use-related risks5.7Combination devices5.8Software with complex interfaces5.9Review by notified bodies5.10Practice: traceability between use risks and validation
6.1Production and post-market activities6.2Collection of field information6.3Review of risk management6.4Trends and vigilance6.5Updating the risk file6.6Periodic Safety Update Report (PSUR)6.7Post-market clinical follow-up6.8Corrective safety actions6.9Cybersecurity over the product lifecycle6.10Workshop: updating the analysis after complaints
7.1Risk management review7.2Notified body audits7.3FDA inspections and expectations7.4Common non-conformities7.5Harmonised standards and presumption of conformity7.6Technical documentation under MDR Annex II7.7Risk management tools7.8Risk management culture7.9Team training7.10Case study: response to a risk-related non-conformity
8.1Device selection8.2Risk management plan8.3Hazard analysis8.4Use specification8.5Risk evaluation and control8.6Interface evaluation plan8.7Overall residual risk evaluation8.8Risk management report8.9Dissertation and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. 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 Greenlight Guru, Polarion ALM, advanced Excel, Qualio, in free, academic or evaluation versions. Assignments are based on real procedures for preparing risk management files, design and process FMEA analyses, and internal compliance audits. Assessment is continuous, module by 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.
Apply the ISO 14971 risk management process.
Carry out risk analyses using techniques such as FMEA and FTA.
Evaluate risks and define control measures.
Apply regulated usability engineering.
Integrate usability analysis into the risk file.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient command 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 comprises 800 hours in total, spread over 6 to 8 months. That works out to an average of 10 to 15 hours per week, compatible with a full-time job.
You will work with Greenlight Guru, Polarion ALM, advanced Excel and Qualio. 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 Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised towards the higher programme. Check the recognition policy when you enrol.
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