Postgraduate Diploma in ISO 14155 and Good Clinical Practice (GCP)
Online 800 h Postgraduate Diploma in ISO 14155 and Good Clinical Practice (GCP). 8 modules covering ISO 14155 (clinical investigation of medical devices), Regulation (EU) 2017/745 (medical devices) and REDCap. Assigned tutor and open enrolment.
Postgraduate Diploma in ISO 14155 and Good Clinical Practice (GCP) — studying from South Africa
Health technology and occupational safety are important in South Africa, where mining, manufacturing and healthcare all require strong safety engineering. The Medicines Control Council regulates medical devices, and the Department of Employment and Labour enforces workplace health and safety legislation. Hospitals, medical device distributors and research groups at universities use biomechanics and wearable technology to improve care and worker protection. Demand exists for engineers who can combine human factors knowledge with regulatory compliance.
Fees for South Africa: R 16 700 (South African rand), with instalments and employer sponsorship available.
Relevant bodies in South Africa
Typical roles
Questions from South Africa
Will a SEIUM qualification be recognised by the professional bodies in South Africa for this area?
SEIUM qualifications are private qualifications, not official state degrees, and they are not accredited by any South African body. Engineering registration in South Africa is handled by the Engineering Council of South Africa (ECSA), which registers people based on their own accredited training and experience. Recognition of a private qualification is therefore decided by individual employers or the relevant professional body, so check with them before enrolling.
How might this qualification be used by employers in South Africa in health-related engineering or occupational safety?
Employers in medical devices, occupational health, and workplace safety may value advanced, specialised knowledge in biomechanics and wearable technology, especially when paired with practical experience. Because the qualification is private rather than state-recognised, its weight depends on each employer's view. Speak to potential employers in your sector about whether they would consider it alongside your existing qualifications and work history.
Can I study this programme alongside full-time work from South Africa, and is there a time zone or language issue?
The programme is 100% online and taught in English, so you can study from home without a student visa. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, with an assigned technical tutor and fees payable in instalments. Employer sponsorship is possible. Confirm the schedule and time-zone expectations with SEIUM before enrolling, as these details are not covered here.
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What you will be able to do
Describe the framework for clinical investigation of medical devices.
Apply the requirements of ISO 14155 throughout the study.
Design a clinical investigation plan using a robust methodology.
Prepare the documentation and authorisation applications.
Conduct and monitor an investigation in compliance with GCP.
Manage and report adverse events.
Ensure data quality and prepare the final report.
Who it's for
- Clinical trial monitor (CRA) looking to specialise in ISO 14155 and Good Clinical Practice (GCP).
- Clinical investigation manager for medical devices looking to specialise in ISO 14155 and Good Clinical Practice (GCP).
- Clinical affairs specialist looking to specialise in ISO 14155 and Good Clinical Practice (GCP).
- Clinical trial coordinator looking to specialise in ISO 14155 and Good Clinical Practice (GCP).
- Good clinical practice auditor looking to specialise in ISO 14155 and Good Clinical Practice (GCP).
- Head of clinical investigation vigilance looking to specialise in ISO 14155 and Good Clinical Practice (GCP).
- Engineering or science graduates seeking to join medical device manufacturers.
What you'll work with
- ISO 14155 (clinical investigation of medical devices)
- Regulation (EU) 2017/745 (medical devices)
- ICH E6(R2) (good clinical practice)
- Declaration of Helsinki
- MDCG 2020-10/1 (safety reporting in clinical investigations)
- Royal Decree 192/2023 (medical devices)
- Regulation (EU) 2016/679 (GDPR)
8 modules · 800 h
1.1Clinical investigation versus clinical evaluation1.2MDR Regulation 2017/745: Chapter VI and Annex XV1.3Types of clinical investigations1.4Pre- and post-market studies1.5Differences from medicinal product trials1.6Royal Decree 192/2023 in Spain1.7Competent authority: AEMPS1.8EUDAMED databases1.9Declaration of Helsinki1.10Case study: classifying a study involving a device
2.1Structure and scope of ISO 14155:20202.2Ethical principles and good clinical practice2.3Investigation planning2.4Risk management in the investigation2.5Sponsor responsibilities2.6Principal investigator responsibilities2.7Monitoring and audits2.8Essential documentation2.9Annexes and informative requirements2.10Practice: ISO 14155 compliance checklist
3.1Objectives and endpoints3.2Designs: randomised, single-arm and observational3.3Sample size calculation3.4Inclusion and exclusion criteria3.5Bias control and blinding3.6Clinical investigation plan (CIP)3.7Investigator's brochure3.8Statistical analysis plan3.9Follow-up and study duration3.10Workshop: drafting the synopsis of a CIP
4.1Research ethics committees4.2Participant information sheet and informed consent4.3Application to the competent authority4.4Insurance and liability4.5Contracts with sites4.6Registration in public study registries4.7Trial master file (TMF)4.8Substantial amendments4.9Document version control4.10Practice: patient information sheet
5.1Site initiation visit5.2Training of the investigation team5.3On-site and remote monitoring5.4Risk-based monitoring5.5Source data verification5.6Investigational product management5.7Protocol deviations5.8Electronic case report forms5.9Site close-out5.10Laboratory: risk-based monitoring plan
6.1Adverse events and serious adverse events6.2Device deficiencies6.3Causality classification6.4Reporting deadlines6.5Data monitoring committee (DMC)6.6Periodic safety reports6.7Suspension and early termination6.8Urgent safety measures6.9Post-market clinical follow-up (PMCF)6.10Case study: reporting a serious adverse event
7.1Clinical data management7.2Data quality and audits7.3Authority inspections7.4Statistical analysis and results7.5Clinical investigation report7.6Publication and transparency7.7Integration into the clinical evaluation report7.8Archiving and record retention7.9Lessons from inspection findings7.10Practice: structure of the final investigation report
8.1Device selection and clinical question8.2Study design8.3Drafting the CIP8.4Documentation for the ethics committee8.5Monitoring plan8.6Safety management plan8.7Data analysis plan8.8Timeline and budget8.9Report 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 timetable: students progress at their own pace within the intake, making it compatible with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is REDCap, Medidata Rave EDC, Veeva Vault CTMS, SAS, in free, academic or evaluation versions. Trials are studied through real procedures for drafting clinical investigation plans, simulated monitoring visits and adverse event management. Assessment is continuous per 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.
Describe the framework for clinical investigation of medical devices.
Apply the requirements of ISO 14155 throughout the study.
Design a clinical investigation plan using a robust methodology.
Prepare the documentation and authorisation applications.
Conduct and monitor an investigation in compliance with GCP.
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. That is between 10 and 15 hours per week on average, compatible with a full-time job.
You will work with REDCap, Medidata Rave EDC, Veeva Vault CTMS, SAS. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM own diploma upon passing the continuous assessment and the integrating project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area can be credited towards the advanced programme. Please check the credit transfer policy when you enrol.
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