Master’s in Regulated Medical Design Engineering
Online master's programme of 1,900 hours in regulated medical design engineering, structured in 12 modules covering the MDR and FDA framework, ISO 13485 quality management, ISO 14971 risk management, medical electronics, medical software, usability, cybersecurity, design verification and validation, clinical evaluation, technical documentation and post-market surveillance, with an assigned technical tutor.
Master’s in Regulated Medical Design Engineering — 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: €7,920 (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
Interpret the European and US regulatory framework for medical devices.
Implement a quality management system compliant with ISO 13485.
Manage product risks according to ISO 14971.
Design safe medical electronics in compliance with IEC 60601-1.
Develop medical software according to IEC 62304 and usability criteria.
Plan verification, validation and clinical evaluation.
Prepare the technical documentation for a regulated medical device.
Who it's for
- Medical device engineers involved in design and development.
- Regulatory affairs specialists preparing MDR and FDA submissions.
- Medical device quality engineers working under ISO 13485.
- Medical software engineers developing to IEC 62304.
- Risk management engineers applying ISO 14971.
- Regulatory compliance managers in medtech companies.
- Engineering or science graduates aiming to work in health technology.
What you'll work with
- Regulation (EU) 2017/745 (Medical Device Regulation, MDR)
- ISO 13485 (quality management systems for medical devices)
- ISO 14971 (application of risk management to medical devices)
- IEC 60601-1 (basic safety and essential performance of medical electrical equipment)
- IEC 62304 (medical device software lifecycle processes)
- IEC 62366-1 (application of usability engineering to medical devices)
- IEC 60601-1-2 (electromagnetic disturbances in medical electrical equipment)
- IEC 81001-5-1 (security in the health software product lifecycle)
- Greenlight Guru
- Jama Connect
- Polarion ALM
- MATLAB
- LabVIEW
12 modules · 1900 h
1.1European Medical Device Regulation1.2In Vitro Diagnostic Medical Device Regulation1.3Classification of devices by rules1.4General safety and performance requirements1.5Notified bodies and assessment1.6UDI unique identification and EUDAMED1.7FDA regulation and the 510(k) pathway1.8Spanish Agency of Medicines and Medical Devices1.9Software as a medical device1.10Case study: classification of a portable monitor
2.1ISO 134852.2Design and development control2.3Document and record management2.4Supplier control2.5Non-conformity management and CAPA2.6Internal audit programme2.7Process validation2.8FDA 21 CFR Part 820 requirements2.9Integration with the lifecycle2.10Workshop: design control procedure
3.1ISO 149713.2Risk management plan3.3Analysis of hazards and hazardous situations3.4Risk estimation and evaluation3.5Risk control measures3.6Residual risk and benefit-risk3.7Risk management report3.8Production and post-production information3.9FMEA tools for medical devices3.10Practical: risk analysis of an infusion pump
4.1Basic safety according to IEC 60601-14.2Means of patient and operator protection4.3Type B, BF and CF applied parts4.4Patient leakage currents4.5Insulation and creepage distances4.6Medical-grade power supplies4.7Electromagnetic compatibility to IEC 60601-1-24.8Home healthcare equipment4.9Alarms in medical equipment4.10Lab: measuring patient leakage currents
5.1IEC 623045.2Software safety classification5.3Software planning and requirements5.4Architecture and detailed design5.5Software of unknown provenance (SOUP)5.6Software verification and testing5.7Maintenance and problem management5.8Medical mobile apps5.9Artificial intelligence in medical devices5.10Practical: development plan for Class B software
6.1IEC 62366-16.2Use specification6.3Task analysis and use errors6.4User interface design6.5Formative evaluation of prototypes6.6Summative validation evaluation6.7Instructions for use6.8Lay users6.9FDA human factors guidance6.10Workshop: formative evaluation of an interface
7.1MDCG 2019-16 guidance7.2FDA premarket cybersecurity requirements7.3IEC 81001-5-17.4Threat modelling in medical devices7.5SBOM in medical devices7.6Post-market vulnerability management7.7Secure interoperability with HL7 FHIR7.8Security in hospitals and clinical networks7.9Coordinated vulnerability disclosure7.10Case study: threat model of a connected pacemaker
8.1Design verification planning8.2Electrical safety tests8.3Essential performance tests8.4Biocompatibility according to ISO 109938.5Sterilisation and packaging8.6Shelf-life and ageing tests8.7Design validation with users8.8Traceability between requirements and tests8.9Transfer to production8.10Lab: verification traceability matrix
9.1Clinical evaluation requirements9.2Clinical data and equivalence9.3Clinical investigations according to ISO 141559.4Clinical evaluation plan9.5Clinical evaluation report9.6Post-market clinical follow-up9.7Performance evaluation in diagnostics9.8Ethics committees and authorisation9.9Biostatistics applied to trials9.10Practical: structure of a clinical evaluation report
10.1Structure of the technical documentation10.2Annexes II and III of the regulation10.3EU declaration of conformity10.4Labelling and symbols10.5FDA submission file10.6Notified body audits10.7MDSAP single audit programme10.8Management of significant changes10.9Certificate maintenance10.10Case study: index of complete technical documentation
11.1Post-market surveillance system11.2Periodic safety update report11.3Reporting serious incidents11.4Field safety corrective actions11.5Trend analysis11.6Complaint handling11.7Feedback to design11.8Person responsible for regulatory compliance11.9Product end of life11.10Workshop: post-market surveillance plan
12.1Definition of the medical device12.2Classification and regulatory strategy12.3Product risk management12.4Hardware and software design12.5Usability and cybersecurity12.6Verification and clinical validation plan12.7Draft technical documentation12.8Conclusions on the medical device12.9Master's Thesis report12.10Master's Thesis: defence before a panel
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: you progress at your own pace within each intake, so the programme fits around your job.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Greenlight Guru, Jama Connect, Polarion ALM, MATLAB and LabVIEW, in free, academic or evaluation versions. Testing is studied through real procedures: measuring leakage currents and electrical safety in medical equipment, preparing risk analyses according to ISO 14971, and formative usability evaluations with users. Assessment is continuous by module, plus the final Master's Thesis.
Standards covered: Regulation (EU) 2017/745, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, IEC 62366-1, IEC 60601-1-2, IEC 81001-5-1.
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
- A university degree in engineering, science or architecture, or equivalent demonstrable professional experience.
- An internet connection and a computer capable of running the programme's 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 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with Greenlight Guru, Jama Connect, Polarion ALM, MATLAB and LabVIEW, 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 Master's Thesis. 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 in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.
A university degree in engineering, science or architecture (or equivalent professional experience), a computer able to run the programme's 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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