Postgraduate Diploma in IEC 62304: Medical Software Lifecycle
800-hour online Postgraduate Diploma in IEC 62304: Medical Software Lifecycle. 8 modules covering IEC 62304 (software lifecycle processes for medical devices), ISO 14971 and Jira. Assigned tutor and open enrolment.
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Run a real engineering trade-off from this programme. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Determine when software is a medical device and its class.
Plan development according to the safety class of IEC 62304.
Specify traceable software requirements and architecture.
Implement detailed design with secure coding practices.
Integrate, test and release software with documented evidence.
Manage software risks, including cybersecurity risks.
Maintain software and manage its configuration and problems.
Who it's for
- Medical device software engineer who wants to specialise in IEC 62304: Medical Software Lifecycle.
- Software quality manager who wants to specialise in IEC 62304: Medical Software Lifecycle.
- Verification and validation engineer who wants to specialise in IEC 62304: Medical Software Lifecycle.
- Medical software architect who wants to specialise in IEC 62304: Medical Software Lifecycle.
- Software regulatory specialist who wants to specialise in IEC 62304: Medical Software Lifecycle.
- DevOps engineer in regulated environments who wants to specialise in IEC 62304: Medical Software Lifecycle.
- Engineering or science graduates looking to enter medical device manufacturers.
What you'll work with
- IEC 62304 (software lifecycle processes for medical devices)
- ISO 14971
- IEC 82304-1 (health software, standalone)
- IEC 81001-5-1 (cybersecurity in health software)
- MDCG 2019-11 (qualification and classification of software)
- IEC 62366-1
- FDA guidance Content of Premarket Submissions for Device Software Functions (2023)
8 modules · 800 h
1.1Software as a medical device (SaMD)1.2Software in a medical device1.3Rule 11 of the MDR and classification1.4MDCG 2019-11 guidance1.5IMDRF framework for SaMD1.6Relationship between IEC 62304, ISO 13485 and ISO 149711.7Software safety classification A, B and C1.8IEC 62304:2015 amendment1.9AI software as a medical device1.10Case study: classifying a diagnostic app
2.1Software development plan2.2Lifecycle models: waterfall, V-model and iterative2.3Agile development in regulated environments: AAMI TIR452.4Standards, methods and tools2.5Integration and testing plan2.6Configuration management plan2.7Problem resolution plan2.8Deliverables and documentation2.9Risk management in planning2.10Practice: development plan for a class B software
3.1Software requirements analysis3.2Functional, safety and usability requirements3.3Risk control measures in requirements3.4Software architecture and elements3.5Segregation of software items3.6SOUP: identification and requirements3.7Interfaces with hardware and systems3.8Architecture verification3.9Requirements traceability3.10Workshop: architecture design with segregation
4.1Software units and detailed design4.2Unit acceptance criteria4.3Coding standards: MISRA and similar4.4Static code analysis4.5Code reviews4.6Unit verification4.7Automated unit testing4.8Code coverage4.9Technical debt management4.10Laboratory: unit testing and static analysis in a repository
5.1Software integration5.2Integration testing5.3Software system testing5.4Regression testing5.5Management of known anomalies5.6Evaluation of residual anomalies5.7Software release and versioning5.8Archiving and build reproducibility5.9Regulated continuous integration and delivery5.10Practice: system verification report
6.1Analysis of software contribution to hazardous situations6.2Causes of software failure6.3Risk control measures in software6.4Verification of control measures6.5Risks associated with SOUP6.6Cybersecurity and IEC 81001-5-16.7Change risk management6.8Software risk documentation6.9Interaction with the risk file6.10Case study: risk analysis of a dose calculation module
7.1Software maintenance plan7.2Feedback and surveillance7.3Problem and modification analysis7.4Configuration management and change control7.5SOUP version management7.6Security patches7.7Legacy software and IEC 623047.8Audits of the software process7.9Expectations of notified bodies and the FDA7.10Workshop: resolution workflow for a field problem
8.1Software product definition8.2Safety classification8.3Development plan8.4Requirements and architecture8.5Risk analysis8.6Verification strategy8.7Maintenance plan8.8Documentation file8.9Report and presentation8.10Final review with the tutor
How you'll learn
Fully 100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetable: students progress at their own pace within the enrolment period, making it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Jira, Polarion ALM, Git, SonarQube, in free, academic or evaluation versions. Assessments are studied using real procedures for requirement-to-test traceability reviews, automated unit and integration testing, and static code analysis. 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.
Determine when software is a medical device and its class.
Plan development according to the safety class of IEC 62304.
Specify traceable software requirements and architecture.
Implement detailed design with secure coding practices.
Integrate, test and release software with documented evidence.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not 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. This is between 10 and 15 hours per week on average, compatible with full-time work.
You will work with Jira, Polarion ALM, Git and SonarQube. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM diploma on passing the continuous assessment and the integrating project. This is SEIUM's own training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area count towards the higher-level programme. Please consult the credit recognition policy when you enrol.
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