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Master'sHealth, Biomechanics, Wearables & Operational Safety Applications open

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.

Duration1900 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Design medical electrical equipment in accordance with IEC 60601-1.

02

Apply appropriate means of protection and insulation distances.

03

Ensure the electromagnetic compatibility of the device.

04

Develop isolated analogue stages for biomedical signals.

05

Analyse the functional safety and reliability of hardware.

06

Protect hardware against cybersecurity threats.

07

Plan the verification, validation and industrialisation of the equipment.

Profile

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.
Standards & tools

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
Syllabus

12 modules · 1900 h

  1. 1.1Architecture of medical electrical equipment
  2. 1.2Basic safety and essential performance
  3. 1.3Classification by applied part type
  4. 1.4Leakage currents and physiological effects
  5. 1.5Means of protection: MOOP and MOPP
  6. 1.6Clearance and creepage distances
  7. 1.7Medical power supplies
  8. 1.8Principles of safe design
  9. 1.9Hardware development cycle
  10. 1.10Case study: safety analysis of a commercial ECG
  1. 2.1Structure of the standard and amendments
  2. 2.2Electrical and mechanical hazards
  3. 2.3Protection against excessive temperatures
  4. 2.4Medical electrical systems and Clause 16
  5. 2.5Programmable electrical medical systems (PEMS)
  6. 2.6Accompanying documents and marking
  7. 2.7Type testing
  8. 2.8Particular standards of the 60601-2 family
  9. 2.9CB test reports and test laboratories
  10. 2.10Practical exercise: test list for a class II device
  1. 3.1IEC 60601-1-2 requirements
  2. 3.2Conducted and radiated emissions
  3. 3.3Immunity to ESD, transients and fields
  4. 3.4Professional healthcare, home and special environments
  5. 3.5PCB design for EMC
  6. 3.6Filters, shielding and grounding
  7. 3.7Pre-compliance testing
  8. 3.8EMC risk management
  9. 3.9Wireless coexistence under AAMI TIR69
  10. 3.10Laboratory: conducted emissions pre-test
  1. 4.1High-CMRR instrumentation amplifiers
  2. 4.2Noise and its modelling
  3. 4.3Galvanic isolation of signals
  4. 4.4Defibrillation protection
  5. 4.5Sigma-delta analogue-to-digital converters
  6. 4.6References and thermal stability
  7. 4.7Anti-aliasing filter design
  8. 4.8SPICE simulation
  9. 4.9Performance validation
  10. 4.10Practical exercise: isolated front-end for biopotentials
  1. 5.1Microcontrollers and FPGAs in medical devices
  2. 5.2Redundant architectures
  3. 5.3Watchdogs and supervision
  4. 5.4Memories and data corruption
  5. 5.5Communication interfaces
  6. 5.6Design for functional safety
  7. 5.7IEC 62304 in firmware
  8. 5.8Secure boot and cryptography
  9. 5.9Hardware-in-the-loop firmware testing
  10. 5.10Laboratory: supervision with an external watchdog
  1. 6.1IEC 61508 concepts applied
  2. 6.2FMEDA of circuits
  3. 6.3Fault trees
  4. 6.4Failure rate calculation
  5. 6.5Design of alarms and safe states
  6. 6.6Predicted and demonstrated reliability
  7. 6.7HALT/HASS accelerated life testing
  8. 6.8Component derating
  9. 6.9Component obsolescence
  10. 6.10Practical exercise: FMEDA of a power stage
  1. 7.1Physical and side-channel threats
  2. 7.2Secure elements and TPM
  3. 7.3Key management in manufacturing
  4. 7.4Debug ports and their protection
  5. 7.5Signed firmware and updates
  6. 7.6IEC 81001-5-1 for the product
  7. 7.7MDCG 2019-16 requirements for hardware
  8. 7.8Hardware and firmware SBOM
  9. 7.9Security testing
  10. 7.10Workshop: threat analysis of a medical board
  1. 8.1Enclosure design and IP protection
  2. 8.2Mechanical impact and drop testing
  3. 8.3Thermal management and contact temperatures
  4. 8.4Biocompatibility of contact parts
  5. 8.5Surface cleaning and disinfection
  6. 8.6Flammability of materials
  7. 8.7Design for manufacturing
  8. 8.8Assembly and tolerances
  9. 8.9Environmental temperature and humidity testing
  10. 8.10Practical exercise: thermal simulation of a portable device
  1. 9.1Batteries in medical equipment
  2. 9.2IEC 62133-2 battery safety
  3. 9.3Medically certified power supplies
  4. 9.4Uninterruptible power supply systems
  5. 9.5Battery monitoring and alarms
  6. 9.6Charging in the clinical environment
  7. 9.7Battery transport
  8. 9.8Minimum autonomy in medical transport
  9. 9.9Power supply risk management
  10. 9.10Case study: power supply of a transport ventilator
  1. 10.1Design verification plan
  2. 10.2Traceability of hardware requirements
  3. 10.3Testing at independent test laboratories
  4. 10.4Production testing
  5. 10.5Validation of manufacturing processes
  6. 10.6Non-conformity management
  7. 10.7Test reports
  8. 10.8Design changes and re-verification
  9. 10.9Hardware technical documentation
  10. 10.10Practical exercise: verification plan for a pulse oximeter
  1. 11.1Design transfer to production
  2. 11.2EMS providers and their control
  3. 11.3End-of-line testing
  4. 11.4Traceability and UDI
  5. 11.5Management of critical components
  6. 11.6Post-market surveillance of field failures
  7. 11.7Repair and technical service
  8. 11.8End of life and WEEE
  9. 11.9Hardware sustainability
  10. 11.10Case study: transfer to a contract manufacturer
  1. 12.1Medical device specification
  2. 12.2Initial risk analysis
  3. 12.3Secure hardware architecture
  4. 12.4Schematic and PCB design
  5. 12.5EMC and electrical safety strategy
  6. 12.6Firmware and cybersecurity
  7. 12.7Verification plan
  8. 12.8Hardware technical file
  9. 12.9Thesis report
  10. 12.10Master's Thesis: defence before a panel
Methodology, software & labs

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.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of IEC 60601-1, IEC 60601-1-2 and IEC 62304 applied to real cases, not as a theoretical annex.
Industry software:Altium Designer, LTspice, ANSYS Icepak, MATLAB and KiCad, in free, academic or evaluation versions.
Master's Thesis with defence:A safe medical hardware design, from specification and risk analysis to PCB, verification plan and technical file, defended before a panel.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Specification and risk analysis
Specify the medical device and carry out the initial risk analysis.
Secure hardware architecture
Define a secure hardware architecture with its firmware and cybersecurity approach.
Schematic and PCB design
Design the schematics and PCB with an EMC and electrical safety strategy.
Verification plan
Plan the verification of the design against IEC 60601 requirements.
Master's Thesis
A medical hardware design with its technical file, defended before a panel.
Career opportunities

Where this takes you

Medical hardware engineerElectrical safety engineerEMC engineerFirmware engineerVerification and validation engineerIndustrialisation engineer
Admissions & scholarships

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.

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FAQ

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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