Master’s in Medical Hardware Design and Safe Electronics Engineering
Online master's programme of 1,900 hours in medical hardware design and safe electronics engineering. 12 modules covering IEC 60601-1 electrical safety, EMC, analogue design for biomedical signals, embedded systems, functional safety and reliability, hardware cybersecurity, mechanics and thermal design, batteries, verification and validation and industrialisation, with an assigned technical tutor.
Master’s in Medical Hardware Design and Safe Electronics Engineering — studying from South Africa
Health technology and occupational safety are important in South Africa, where mining, manufacturing and healthcare all require strong safety engineering. The Medicines Control Council regulates medical devices, and the Department of Employment and Labour enforces workplace health and safety legislation. Hospitals, medical device distributors and research groups at universities use biomechanics and wearable technology to improve care and worker protection. Demand exists for engineers who can combine human factors knowledge with regulatory compliance.
Fees for South Africa: R 148 000 (South African rand), with instalments and employer sponsorship available.
Relevant bodies in South Africa
Typical roles
Questions from South Africa
Will a SEIUM qualification be recognised by the professional bodies in South Africa for this area?
SEIUM qualifications are private qualifications, not official state degrees, and they are not accredited by any South African body. Engineering registration in South Africa is handled by the Engineering Council of South Africa (ECSA), which registers people based on their own accredited training and experience. Recognition of a private qualification is therefore decided by individual employers or the relevant professional body, so check with them before enrolling.
How might this qualification be used by employers in South Africa in health-related engineering or occupational safety?
Employers in medical devices, occupational health, and workplace safety may value advanced, specialised knowledge in biomechanics and wearable technology, especially when paired with practical experience. Because the qualification is private rather than state-recognised, its weight depends on each employer's view. Speak to potential employers in your sector about whether they would consider it alongside your existing qualifications and work history.
Can I study this programme alongside full-time work from South Africa, and is there a time zone or language issue?
The programme is 100% online and taught in English, so you can study from home without a student visa. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, with an assigned technical tutor and fees payable in instalments. Employer sponsorship is possible. Confirm the schedule and time-zone expectations with SEIUM before enrolling, as these details are not covered here.
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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
Design medical electrical equipment in accordance with IEC 60601-1.
Apply appropriate means of protection and insulation distances.
Ensure the electromagnetic compatibility of the device.
Develop isolated analogue stages for biomedical signals.
Analyse the functional safety and reliability of hardware.
Protect hardware against cybersecurity threats.
Plan the verification, validation and industrialisation of the equipment.
Who it's for
- Medical hardware engineers.
- Electrical safety engineers.
- EMC engineers.
- Firmware engineers.
- Verification and validation engineers.
- Industrialisation engineers.
- Engineering or science graduates looking to enter the medical device sector.
What you'll work with
- IEC 60601-1 (basic safety and essential performance)
- IEC 60601-1-2 (electromagnetic compatibility)
- IEC 62304 (software life cycle)
- ISO 14971 (risk management)
- IEC 62133-2 (battery safety)
- IEC 81001-5-1 (cybersecurity)
- Regulation (EU) 2017/745 (medical devices)
- IEC 61508 (functional safety)
- Altium Designer
- LTspice
- ANSYS Icepak
- MATLAB
- KiCad
12 modules · 1900 h
1.1Architecture of medical electrical equipment1.2Basic safety and essential performance1.3Classification by applied part type1.4Leakage currents and physiological effects1.5Means of protection: MOOP and MOPP1.6Clearance and creepage distances1.7Medical power supplies1.8Principles of safe design1.9Hardware development cycle1.10Case study: safety analysis of a commercial ECG
2.1Structure of the standard and amendments2.2Electrical and mechanical hazards2.3Protection against excessive temperatures2.4Medical electrical systems and Clause 162.5Programmable electrical medical systems (PEMS)2.6Accompanying documents and marking2.7Type testing2.8Particular standards of the 60601-2 family2.9CB test reports and test laboratories2.10Practical exercise: test list for a class II device
3.1IEC 60601-1-2 requirements3.2Conducted and radiated emissions3.3Immunity to ESD, transients and fields3.4Professional healthcare, home and special environments3.5PCB design for EMC3.6Filters, shielding and grounding3.7Pre-compliance testing3.8EMC risk management3.9Wireless coexistence under AAMI TIR693.10Laboratory: conducted emissions pre-test
4.1High-CMRR instrumentation amplifiers4.2Noise and its modelling4.3Galvanic isolation of signals4.4Defibrillation protection4.5Sigma-delta analogue-to-digital converters4.6References and thermal stability4.7Anti-aliasing filter design4.8SPICE simulation4.9Performance validation4.10Practical exercise: isolated front-end for biopotentials
5.1Microcontrollers and FPGAs in medical devices5.2Redundant architectures5.3Watchdogs and supervision5.4Memories and data corruption5.5Communication interfaces5.6Design for functional safety5.7IEC 62304 in firmware5.8Secure boot and cryptography5.9Hardware-in-the-loop firmware testing5.10Laboratory: supervision with an external watchdog
6.1IEC 61508 concepts applied6.2FMEDA of circuits6.3Fault trees6.4Failure rate calculation6.5Design of alarms and safe states6.6Predicted and demonstrated reliability6.7HALT/HASS accelerated life testing6.8Component derating6.9Component obsolescence6.10Practical exercise: FMEDA of a power stage
7.1Physical and side-channel threats7.2Secure elements and TPM7.3Key management in manufacturing7.4Debug ports and their protection7.5Signed firmware and updates7.6IEC 81001-5-1 for the product7.7MDCG 2019-16 requirements for hardware7.8Hardware and firmware SBOM7.9Security testing7.10Workshop: threat analysis of a medical board
8.1Enclosure design and IP protection8.2Mechanical impact and drop testing8.3Thermal management and contact temperatures8.4Biocompatibility of contact parts8.5Surface cleaning and disinfection8.6Flammability of materials8.7Design for manufacturing8.8Assembly and tolerances8.9Environmental temperature and humidity testing8.10Practical exercise: thermal simulation of a portable device
9.1Batteries in medical equipment9.2IEC 62133-2 battery safety9.3Medically certified power supplies9.4Uninterruptible power supply systems9.5Battery monitoring and alarms9.6Charging in the clinical environment9.7Battery transport9.8Minimum autonomy in medical transport9.9Power supply risk management9.10Case study: power supply of a transport ventilator
10.1Design verification plan10.2Traceability of hardware requirements10.3Testing at independent test laboratories10.4Production testing10.5Validation of manufacturing processes10.6Non-conformity management10.7Test reports10.8Design changes and re-verification10.9Hardware technical documentation10.10Practical exercise: verification plan for a pulse oximeter
11.1Design transfer to production11.2EMS providers and their control11.3End-of-line testing11.4Traceability and UDI11.5Management of critical components11.6Post-market surveillance of field failures11.7Repair and technical service11.8End of life and WEEE11.9Hardware sustainability11.10Case study: transfer to a contract manufacturer
12.1Medical device specification12.2Initial risk analysis12.3Secure hardware architecture12.4Schematic and PCB design12.5EMC and electrical safety strategy12.6Firmware and cybersecurity12.7Verification plan12.8Hardware technical file12.9Thesis report12.10Master's Thesis: defence before a panel
How you'll learn
Training is 100% online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so the programme is compatible with full-time work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Altium Designer, LTspice, ANSYS Icepak, MATLAB and KiCad, in free, academic or evaluation versions. Testing is studied through real procedures: EMC pre-compliance testing, leakage current measurements and accelerated reliability testing. Assessment is continuous by module, plus the final Master's Thesis.
Standards covered: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, IEC 62133-2, IEC 81001-5-1, Regulation (EU) 2017/745, IEC 61508.
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 Altium Designer, LTspice, ANSYS Icepak, MATLAB and KiCad, 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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