Master’s in Medical Devices, Software & Regulation Engineering
Online master's programme of 1,900 hours in medical device, software and regulatory engineering. 12 modules covering the MDR, ISO 13485 quality management, ISO 14971 risk management, IEC 60601 hardware, IEC 62304 software, cybersecurity, usability, clinical evaluation, biocompatibility and post-market surveillance, with an assigned technical tutor.
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
Classify medical devices and define their conformity pathway under the MDR.
Implement a quality management system compliant with ISO 13485.
Apply ISO 14971 risk management to hardware and software.
Design medical hardware in accordance with the IEC 60601 series.
Develop medical software under IEC 62304 with built-in cybersecurity.
Plan clinical evaluation and post-market surveillance.
Prepare technical documentation for notified bodies and the FDA.
Who it's for
- Medical device engineers.
- Regulatory affairs specialists.
- ISO 13485 quality managers.
- Medical software engineers.
- Product risk managers.
- Notified body auditors.
- Engineering or science graduates looking to join medical device manufacturers.
What you'll work with
- Regulation (EU) 2017/745 (medical devices)
- ISO 13485 (quality management systems)
- ISO 14971 (risk management)
- IEC 60601-1 (safety of medical electrical equipment)
- IEC 62304 (software life cycle)
- IEC 62366-1 (usability engineering)
- ISO 10993-1 (biological evaluation)
- ISO 14155 (clinical investigation of medical devices)
- Greenlight Guru
- Jama Connect
- MATLAB
- Polarion ALM
- Minitab
12 modules · 1900 h
1.1Legal definition of a medical device1.2Types: active, implantable and diagnostic1.3Product life cycle1.4Economic operators: manufacturer, authorised representative, importer and distributor1.5European and US markets1.6Role of the Spanish Agency of Medicines and Medical Devices (AEMPS)1.7Innovation and market access barriers1.8Combination and drug-device products1.9Structure of a medtech company1.10Case study: analysis of a device on the market
2.1Structure of Regulation (EU) 2017/7452.2Annex VIII classification rules2.3General safety and performance requirements2.4Technical documentation under Annexes II and III2.5Conformity assessment procedures2.6Designation and role of notified bodies2.7UDI and EUDAMED2.8Person responsible for regulatory compliance2.9Transition from Directive 93/42/EEC2.10Practical exercise: classifying five devices
3.1ISO 13485 and its requirements3.2Document and record control3.3Design and development control3.4Management of critical suppliers3.5Corrective and preventive actions (CAPA)3.6Internal system audits3.7Process validation3.8FDA 21 CFR Part 820 and the QMSR3.9MDSAP as a single audit programme3.10Workshop: design control procedure
4.1ISO 14971 and its process4.2Preliminary hazard analysis4.3Design and process FMEA4.4Fault tree analysis4.5Residual risk evaluation4.6Overall benefit-risk analysis of the device4.7ISO/TR 24971 as guidance4.8Integration with usability and software4.9Vigilance and feedback4.10Practical exercise: risk management file for a pump
5.1IEC 60601-1 basic safety5.2IEC 60601-1-2 electromagnetic compatibility5.3Particular standards of the 60601-2 series5.4Design for electrical safety5.5Reliability and failure analysis5.6Testing at independent test laboratories5.7Alarms under IEC 60601-1-85.8Home healthcare equipment under IEC 60601-1-115.9The IECEE CB scheme5.10Case study: test plan for a patient monitor
6.1IEC 62304 and software safety classes6.2Software requirements and architecture6.3SOUP and third-party components6.4Verification and unit testing6.5Configuration and problem management6.6Software maintenance6.7Software as a medical device: Rule 116.8MDCG 2019-11 for qualification6.9Continuous integration in a regulated environment6.10Laboratory: development plan under IEC 62304
7.1IEC 81001-5-1 secure life cycle7.2MDCG 2019-16 cybersecurity guidance7.3Threat modelling7.4SBOM and vulnerability management7.5Penetration testing7.6FDA cybersecurity requirements7.7AAMI TIR57 and security risk management7.8Secure field updates7.9Coordinated incident response7.10Workshop: STRIDE threat model of a device
8.1IEC 62366-1 usability engineering process8.2Use specification and user profiles8.3Task analysis and hazard-related use scenarios8.4Formative evaluations with prototypes8.5Summative validation with representative users8.6Labelling and instructions for use8.7Use errors and their mitigation8.8FDA human factors guidance8.9Lay and professional users8.10Practical exercise: summative validation protocol
9.1Clinical evidence strategy for the device9.2Equivalence and its justification9.3Systematic literature review9.4Clinical investigations and ISO 141559.5MEDDEV 2.7/1 rev. 49.6Post-market clinical follow-up9.7Clinical evaluation report9.8Real-world data9.9Clinical performance of software9.10Case study: clinical strategy for an implant
10.1ISO 10993-1 biological evaluation10.2Cytotoxicity and sensitisation testing10.3Chemical characterisation under ISO 10993-1810.4Ethylene oxide sterilisation10.5Radiation sterilisation10.6Packaging validation under ISO 1160710.7Cleaning and reprocessing10.8Shelf life and accelerated ageing10.9ISO 14644 cleanrooms10.10Practical exercise: biological evaluation plan for a catheter
11.1Post-market surveillance plan11.2PSUR and periodic reports11.3Incident reporting and FSCA11.4Trends and indicators11.5FDA registration: 510(k), De Novo and PMA11.6Access to international markets11.7Notified body audits11.8Complaint handling11.9Communication with authorities11.10Case study: managing a field safety corrective action
12.1Device definition and intended purpose12.2Classification and regulatory pathway12.3Traceable design requirements12.4Device risk management12.5Software and cybersecurity plan12.6Verification and validation strategy12.7Clinical evaluation plan12.8Summary 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 Greenlight Guru, Jama Connect, MATLAB, Polarion ALM and Minitab, in free, academic or evaluation versions. Work is based on real procedures: preparation of technical files, planning of electrical safety tests and simulated quality system audits. 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, ISO 10993-1, ISO 14155.
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, MATLAB, Polarion ALM and Minitab, 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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