Master’s in Regulated Medical Design
Online master's programme of 1,900 hours in regulated medical device design (IEC 60601, ISO 13485 and clinical risk for healthcare electronics): 12 modules covering the MDR and IVDR, quality management, risk management, design controls, electrical safety and EMC, medical software, usability, biocompatibility, clinical evaluation, CE marking and post-market surveillance, with an assigned technical tutor.
Master’s in Regulated Medical Design — 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: €6,920 (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 medical device regulations.
Implement an ISO 13485 quality management system.
Manage risk in accordance with ISO 14971.
Apply design controls throughout development.
Meet electrical safety, software and usability requirements.
Plan biocompatibility and clinical evaluation.
Prepare technical documentation and post-market surveillance.
Who it's for
- Medical device design engineers.
- Regulatory affairs specialists.
- Medical device quality engineers.
- Risk management engineers.
- Medical usability engineers.
- Technical documentation managers.
- Engineering or science graduates seeking to enter the medical device sector.
What you'll work with
- Regulation (EU) 2017/745 (MDR) (medical devices)
- 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)
- IEC 62366-1 (usability engineering for medical devices)
- ISO 10993-1 (biological evaluation of medical devices)
- Regulation (EU) 2017/746 (IVDR) (in vitro diagnostic medical devices)
- Greenlight Guru
- Jama Connect
- Polarion
- MasterControl
- SolidWorks
12 modules
1.1Regulation (EU) 2017/7451.2Regulation (EU) 2017/746 on in vitro diagnostics1.3Device classification1.4General safety and performance requirements1.5Notified bodies1.6AEMPS and competent authorities1.7FDA and the 510(k) and PMA pathways1.8The EUDAMED database1.9Person responsible for regulatory compliance1.10Case study: classifying three medical devices
2.1ISO 134852.2Design control2.3Document and record control2.4Supplier management2.5Corrective and preventive actions2.6Internal audits2.721 CFR Part 820 and QMSR2.8MDSAP2.9Quality indicators2.10Practical exercise: design control procedure
3.1ISO 149713.2Risk management plan3.3Hazard identification3.4Risk estimation and evaluation3.5Risk control3.6Residual risk and benefit3.7FMEA and FTA3.8Information for safety3.9Risk management report3.10Lab: risk analysis of an infusion pump
4.1Design inputs4.2User needs4.3Product requirements4.4System architecture4.5Design reviews4.6Design verification4.7Design validation4.8Transfer to production4.9Design History File4.10Practical exercise: requirements traceability matrix
5.1IEC 60601-1 and basic safety5.2MOPP and MOOP means of protection5.3Leakage currents5.4Applied parts5.5IEC 60601-1-2 and EMC5.6Particular standards 60601-25.7Home healthcare equipment IEC 60601-1-115.8Alarms IEC 60601-1-85.9Laboratory testing5.10Lab: leakage current measurement
6.1IEC 62304 and the lifecycle6.2Software safety classification6.3Software as a medical device6.4MDCG 2019-11 guidance6.5SOUP management6.6Software testing6.7Maintenance and changes6.8Cybersecurity IEC 81001-5-16.9AI in medical devices6.10Practical exercise: development plan to IEC 62304
7.1IEC 62366-17.2Use specification7.3Hazard-related use scenarios7.4Formative evaluations7.5Summative evaluation7.6Instructions for use7.7Labelling ISO 15223-17.8Patient interfaces7.9Professional users7.10Workshop: formative evaluation with users
8.1ISO 10993-1 and biological evaluation8.2Contact categories8.3Cytotoxicity testing8.4Sensitisation and irritation8.5Extractables and leachables8.6Material selection8.7Sterilisation ISO 11135 and ISO 111378.8Sterile packaging ISO 116078.9Shelf life8.10Case study: biocompatibility plan for a device
9.1Clinical evaluation under the MDR9.2Clinical evaluation plan9.3Equivalence9.4Clinical investigations ISO 141559.5Ethics committees9.6Performance data9.7Clinical evaluation report9.8Post-market clinical follow-up9.9Performance evaluation for IVDs9.10Practical exercise: structure of a CEP
10.1MDR Annexes II and III10.2Technical file10.3EU declaration of conformity10.4Unique Device Identification (UDI)10.5Conformity assessment procedures10.6Notified body audits10.7Certificates and surveillance10.8Significant changes10.9Language requirements10.10Workshop: technical documentation index
11.1Post-market surveillance plan11.2PSUR reports11.3Vigilance and serious incidents11.4Field safety corrective actions11.5Trend reporting11.6Complaints11.7Product recalls11.8Cybersecurity in the field11.9Continuous improvement11.10Case study: managing a vigilance incident
12.1Device and intended use12.2Classification and regulatory strategy12.3Risk management12.4Requirements and design12.5Verification plan12.6Usability12.7Clinical evaluation12.8Technical documentation12.9Master's Thesis report12.10Master's Thesis: defence before a panel
How you'll learn
100% online programme on the SEIUM campus, with downloadable material, recorded lectures and an assigned technical tutor. No fixed timetables: you progress at your own pace within each intake, so it 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, MasterControl and SolidWorks, in free, academic or evaluation versions. Testing is studied on real procedures: electrical safety and EMC testing, usability evaluations with users and biocompatibility testing. Assessment is continuous by module, plus the final Master's Thesis.
Standards covered: Regulation (EU) 2017/745 (MDR), ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, IEC 62366-1, ISO 10993-1, Regulation (EU) 2017/746 (IVDR).
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
- University degree in engineering, science or architecture, or equivalent demonstrable professional experience.
- Internet connection and a computer capable of running the programme 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, MasterControl and SolidWorks, 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 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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