Master'sElectronics, Embedded Systems & Telecom Applications open

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.

Duration1,900 hours · 12–14 months

ModeOnline

LanguageEnglish

Start datesSet by the faculty

AwardSEIUM Institute diploma

Enrol now View syllabus Ask an advisor

Master’s in Regulated Medical Design — studying from Australia

Electronics and embedded systems underpin a wide range of Australian industries, including defence, mining automation, medical devices and consumer technology. The telecommunications sector is significant, with ongoing investment in fibre, mobile networks and satellite communications for remote regions. Research organisations such as CSIRO and university groups contribute to advances in sensing, communications and signal processing. Engineers typically work on hardware design, firmware development, testing and certification. Employers include telecommunications carriers, defence contractors, instrumentation companies and product manufacturers.

Fees for Australia: A$11,000 (AUD), with instalments and employer sponsorship available.

Relevant bodies in Australia

Australian Communications and Media Authority (ACMA)
Engineers Australia
Standards Australia
Telecommunications Industry Ombudsman

Typical roles

Embedded Systems Engineer
Electronics Design Engineer
Firmware Engineer
Telecommunications Engineer

Questions from Australia

Is this qualification recognised for electronics engineering in Australia?

SEIUM's qualifications are private and not official state degrees, and they are not accredited by Engineers Australia or the Australian Communications and Media Authority. Recognition for electronics and telecom roles generally depends on accredited degrees, licences and experience. Employers or the relevant body make the final decision.

Which Australian employers hire embedded and telecom engineers?

Australia has telecommunications carriers, defence electronics firms, medical device makers, mining technology companies and IoT developers. Employers mostly assess your hands-on skills, project record and certifications. Ask prospective employers whether they would consider a private online qualification.

Can I study this part-time while working, and how is it supported?

The courses are 100% online and taught in English, so you can study from anywhere in Australia without needing a student visa. Specialist courses take 300 hours, diplomas 800 and master's 1,900. Each student has an assigned technical tutor, fees are payable in instalments, and employer sponsorship may be possible.

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Learning outcomes

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.

Profile

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.

Standards & tools

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

Syllabus

12 modules

1.1Regulation (EU) 2017/745
1.2Regulation (EU) 2017/746 on in vitro diagnostics
1.3Device classification
1.4General safety and performance requirements
1.5Notified bodies
1.6AEMPS and competent authorities
1.7FDA and the 510(k) and PMA pathways
1.8The EUDAMED database
1.9Person responsible for regulatory compliance
1.10Case study: classifying three medical devices

2.1ISO 13485
2.2Design control
2.3Document and record control
2.4Supplier management
2.5Corrective and preventive actions
2.6Internal audits
2.721 CFR Part 820 and QMSR
2.8MDSAP
2.9Quality indicators
2.10Practical exercise: design control procedure

3.1ISO 14971
3.2Risk management plan
3.3Hazard identification
3.4Risk estimation and evaluation
3.5Risk control
3.6Residual risk and benefit
3.7FMEA and FTA
3.8Information for safety
3.9Risk management report
3.10Lab: risk analysis of an infusion pump

4.1Design inputs
4.2User needs
4.3Product requirements
4.4System architecture
4.5Design reviews
4.6Design verification
4.7Design validation
4.8Transfer to production
4.9Design History File
4.10Practical exercise: requirements traceability matrix

5.1IEC 60601-1 and basic safety
5.2MOPP and MOOP means of protection
5.3Leakage currents
5.4Applied parts
5.5IEC 60601-1-2 and EMC
5.6Particular standards 60601-2
5.7Home healthcare equipment IEC 60601-1-11
5.8Alarms IEC 60601-1-8
5.9Laboratory testing
5.10Lab: leakage current measurement

6.1IEC 62304 and the lifecycle
6.2Software safety classification
6.3Software as a medical device
6.4MDCG 2019-11 guidance
6.5SOUP management
6.6Software testing
6.7Maintenance and changes
6.8Cybersecurity IEC 81001-5-1
6.9AI in medical devices
6.10Practical exercise: development plan to IEC 62304

7.1IEC 62366-1
7.2Use specification
7.3Hazard-related use scenarios
7.4Formative evaluations
7.5Summative evaluation
7.6Instructions for use
7.7Labelling ISO 15223-1
7.8Patient interfaces
7.9Professional users
7.10Workshop: formative evaluation with users

8.1ISO 10993-1 and biological evaluation
8.2Contact categories
8.3Cytotoxicity testing
8.4Sensitisation and irritation
8.5Extractables and leachables
8.6Material selection
8.7Sterilisation ISO 11135 and ISO 11137
8.8Sterile packaging ISO 11607
8.9Shelf life
8.10Case study: biocompatibility plan for a device

9.1Clinical evaluation under the MDR
9.2Clinical evaluation plan
9.3Equivalence
9.4Clinical investigations ISO 14155
9.5Ethics committees
9.6Performance data
9.7Clinical evaluation report
9.8Post-market clinical follow-up
9.9Performance evaluation for IVDs
9.10Practical exercise: structure of a CEP

10.1MDR Annexes II and III
10.2Technical file
10.3EU declaration of conformity
10.4Unique Device Identification (UDI)
10.5Conformity assessment procedures
10.6Notified body audits
10.7Certificates and surveillance
10.8Significant changes
10.9Language requirements
10.10Workshop: technical documentation index

11.1Post-market surveillance plan
11.2PSUR reports
11.3Vigilance and serious incidents
11.4Field safety corrective actions
11.5Trend reporting
11.6Complaints
11.7Product recalls
11.8Cybersecurity in the field
11.9Continuous improvement
11.10Case study: managing a vigilance incident

12.1Device and intended use
12.2Classification and regulatory strategy
12.3Risk management
12.4Requirements and design
12.5Verification plan
12.6Usability
12.7Clinical evaluation
12.8Technical documentation
12.9Master's Thesis report
12.10Master's Thesis: defence before a panel

Methodology, software & labs

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).

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.

Standards-based learning:guided reading of the MDR (Regulation (EU) 2017/745), ISO 13485 and ISO 14971 applied to real cases, not as a theoretical annex.

Industry software:Greenlight Guru, Jama Connect, Polarion, MasterControl and SolidWorks, in free, academic or evaluation versions.

Master's Thesis with defence:A complete regulatory and design file for a medical device, from intended use and classification to risk management, verification, usability, clinical evaluation and technical documentation, 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.

Regulatory strategy

Define the intended use, classify the device and set its regulatory strategy.

Risk management file

Carry out the ISO 14971 risk analysis with FMEA and FTA.

Design controls

Build the requirements traceability matrix and verification plan.

Usability and clinical evaluation

Plan the usability evaluations and the clinical evaluation of the device.

Master's Thesis

A complete technical documentation file ready for CE marking, defended before a panel.

Career opportunities

Where this takes you

Medical Device Design EngineerRegulatory Affairs SpecialistMedical Device Quality EngineerRisk Management EngineerMedical Usability EngineerTechnical Documentation Manager

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 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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