Postgraduate Diploma in IEC 60601/62304 and Clinical Risk
Online 800-hour Postgraduate Diploma in IEC 60601/62304 and Clinical Risk. 8 modules covering IEC 60601-1, IEC 62304 and Jama Connect. Assigned tutor and open enrolment.
Postgraduate Diploma in IEC 60601/62304 and Clinical Risk — studying from Ireland
Ireland has a substantial electronics and telecommunications sector, with multinational semiconductor, networking and communications firms operating design, test and engineering centres across the country. Universities such as Trinity College Dublin, University College Cork and the Tyndall National Institute contribute research in microelectronics, photonics and communications. Engineers in this area design embedded systems, firmware, RF systems and telecommunications networks for industrial and consumer applications. Standards and spectrum management are overseen by national telecommunications and standards bodies.
Fees for Ireland: €1,490 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Ireland
Typical roles
Questions from Ireland
Which Irish bodies recognise electronics and telecom engineering qualifications?
Engineers Ireland is the main professional body for engineers and runs chartered registration. Telecoms and spectrum matters are regulated by ComReg, the Commission for Communications Regulation. SEIUM's qualifications are private and not state-awarded, and they are not accredited by any national body, so recognition depends on employers or the relevant body.
Do Irish electronics and telecom employers value private online study?
Ireland has a strong electronics, semiconductor and telecoms presence, and employers there usually emphasise hands-on competence, certifications where relevant and experience. A private online qualification may add to your profile, but its value is decided by each employer, and no outcome can be promised. Show practical embedded or RF work alongside it.
Is it feasible alongside work, and what should I expect from the tutoring?
The programme is 100% online and taught in English, so it suits working professionals who can manage their own time. No student visa is needed to study from Ireland. Master's programmes total 1,900 hours, postgraduate diplomas 800 and specialist courses 300. Each student is assigned a technical tutor, fees can be paid in instalments, and employer sponsorship may be possible.
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
Understand the regulatory framework of the MDR and the FDA.
Apply the basic safety requirements of IEC 60601-1.
Plan tests according to collateral and particular standards.
Manage product risk in accordance with ISO 14971.
Apply the software lifecycle according to IEC 62304.
Integrate clinical risk into the product evaluation.
Prepare technical documentation for certification.
Who it's for
- Regulatory affairs engineer who wants to specialise in IEC 60601/62304 and Clinical Risk.
- Risk management engineer who wants to specialise in IEC 60601/62304 and Clinical Risk.
- Medical software engineer who wants to specialise in IEC 60601/62304 and Clinical Risk.
- Electromedical hardware engineer who wants to specialise in IEC 60601/62304 and Clinical Risk.
- Medical device product quality manager who wants to specialise in IEC 60601/62304 and Clinical Risk.
- Verification and validation engineer who wants to specialise in IEC 60601/62304 and Clinical Risk.
- Graduates in engineering or science looking to enter the medical device sector.
What you'll work with
- IEC 60601-1
- IEC 62304
- ISO 14971
- Regulation (EU) 2017/745
- IEC 60601-1-2
- IEC 60601-1-8
- IEC 62366-1
- ISO/TR 24971
8 modules · 800 h
1.1Regulation (EU) 2017/745 MDR1.2Product classification and Rule 111.3General safety and performance requirements1.4Notified bodies and assessment1.5Harmonised and recognised standards1.6FDA framework and 510(k) and De Novo pathways1.7Quality management system ISO 134851.8Software as a medical device1.9Post-market surveillance1.10Case study: classification of a vital signs monitor
2.1Structure of the IEC 60601 series2.2Applied parts of types B, BF and CF2.3Means of protection MOOP and MOPP2.4Leakage currents and tests2.5Insulation and clearances2.6Mechanical and thermal hazards2.7Electromedical systems2.8Accompanying documents and marking2.9Applied risk management file2.10Laboratory: measurement of leakage currents
3.1EMC according to IEC 60601-1-23.2Alarm systems IEC 60601-1-83.3Home healthcare environment IEC 60601-1-113.4Usability IEC 60601-1-63.5Particular standards of the 60601-2 series3.6Requirements for PEMS3.7Immunity testing in clinical environments3.8Certification test plan3.9CB report for medical equipment3.10Practical exercise: test plan for an electromedical device
4.1Risk management process4.2Intended use and foreseeable misuse4.3Identification of hazards and hazardous situations4.4Estimation of probability and severity4.5Risk control and hierarchy of measures4.6Residual risk and benefit-risk balance4.7Risk management report4.8ISO/TR 24971 guidance4.9Risk in production and post-market4.10Workshop: risk analysis of an infusion pump
5.1Safety classification A, B and C5.2Software development plan5.3Software requirements and architecture5.4Segregation of software items5.5SOUP and third-party management5.6Implementation and verification of units5.7System integration and testing5.8Maintenance and problem resolution5.9Configuration management5.10Case study: software classification of a defibrillator
6.1Clinical evaluation under the MDR6.2Clinical evaluation plan and report6.3Equivalence and literature data6.4Clinical investigations per ISO 141556.5Post-market clinical follow-up6.6Software risks in the clinical context6.7Cybersecurity and patient risk6.8Incident management and surveillance6.9Risk review using field data6.10Practical exercise: clinical risk matrix
7.1Technical documentation under Annexes II and III7.2Traceability between risks, requirements and tests7.3Notified body audit7.4Management of significant changes7.5EUDAMED database7.6Unique device identification (UDI)7.7Labelling and instructions for use7.8Global certification strategy7.9Common errors in technical files7.10Case study: technical documentation review
8.1Product description and intended use8.2Regulatory classification8.3Risk analysis per ISO 149718.4IEC 60601-1 requirements8.5IEC 62304 software plan8.6Test plan and clinical evaluation8.7Traceability matrix8.8Certification strategy8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: students progress at their own pace within the intake, which makes it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Jama Connect, Siemens Polarion ALM, Matrix Requirements, LDRA Testbed, Greenlight Guru, in free, academic or evaluation versions. Tests are studied using real procedures for measuring leakage currents, risk analysis of electromedical equipment and technical documentation review. Assessment is continuous, module by module, plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Understand the regulatory framework of the MDR and the FDA.
Apply the basic safety requirements of IEC 60601-1.
Plan tests according to collateral and particular standards.
Manage product risk in accordance with ISO 14971.
Apply the software lifecycle according to IEC 62304.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient Spanish to follow technical regulatory texts.
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 comprises 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
You work with Jama Connect, Siemens Polarion ALM, Matrix Requirements, LDRA Testbed, Greenlight Guru. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM diploma upon passing the continuous assessment and the integrating project. This is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised towards the higher-level programme. Check the recognition policy when you enrol.
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