Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

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.

Duration800 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma

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

  • South African Health Products Regulatory Authority (SAHPRA)
  • Department of Employment and Labour
  • South African Bureau of Standards (SABS)

Typical roles

  • Biomedical Engineer
  • Human Factors Engineer
  • Occupational Safety Engineer
  • Medical Device Engineer

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.

Virtual lab · try it before you enrol

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.

SIM · LIVE ●
Learning outcomes

What you will be able to do

01

Describe the framework for clinical investigation of medical devices.

02

Apply the requirements of ISO 14155 throughout the study.

03

Design a clinical investigation plan using a robust methodology.

04

Prepare the documentation and authorisation applications.

05

Conduct and monitor an investigation in compliance with GCP.

06

Manage and report adverse events.

07

Ensure data quality and prepare the final report.

Profile

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.
Standards & tools

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)
Syllabus

8 modules · 800 h

  1. 1.1Clinical investigation versus clinical evaluation
  2. 1.2MDR Regulation 2017/745: Chapter VI and Annex XV
  3. 1.3Types of clinical investigations
  4. 1.4Pre- and post-market studies
  5. 1.5Differences from medicinal product trials
  6. 1.6Royal Decree 192/2023 in Spain
  7. 1.7Competent authority: AEMPS
  8. 1.8EUDAMED databases
  9. 1.9Declaration of Helsinki
  10. 1.10Case study: classifying a study involving a device
  1. 2.1Structure and scope of ISO 14155:2020
  2. 2.2Ethical principles and good clinical practice
  3. 2.3Investigation planning
  4. 2.4Risk management in the investigation
  5. 2.5Sponsor responsibilities
  6. 2.6Principal investigator responsibilities
  7. 2.7Monitoring and audits
  8. 2.8Essential documentation
  9. 2.9Annexes and informative requirements
  10. 2.10Practice: ISO 14155 compliance checklist
  1. 3.1Objectives and endpoints
  2. 3.2Designs: randomised, single-arm and observational
  3. 3.3Sample size calculation
  4. 3.4Inclusion and exclusion criteria
  5. 3.5Bias control and blinding
  6. 3.6Clinical investigation plan (CIP)
  7. 3.7Investigator's brochure
  8. 3.8Statistical analysis plan
  9. 3.9Follow-up and study duration
  10. 3.10Workshop: drafting the synopsis of a CIP
  1. 4.1Research ethics committees
  2. 4.2Participant information sheet and informed consent
  3. 4.3Application to the competent authority
  4. 4.4Insurance and liability
  5. 4.5Contracts with sites
  6. 4.6Registration in public study registries
  7. 4.7Trial master file (TMF)
  8. 4.8Substantial amendments
  9. 4.9Document version control
  10. 4.10Practice: patient information sheet
  1. 5.1Site initiation visit
  2. 5.2Training of the investigation team
  3. 5.3On-site and remote monitoring
  4. 5.4Risk-based monitoring
  5. 5.5Source data verification
  6. 5.6Investigational product management
  7. 5.7Protocol deviations
  8. 5.8Electronic case report forms
  9. 5.9Site close-out
  10. 5.10Laboratory: risk-based monitoring plan
  1. 6.1Adverse events and serious adverse events
  2. 6.2Device deficiencies
  3. 6.3Causality classification
  4. 6.4Reporting deadlines
  5. 6.5Data monitoring committee (DMC)
  6. 6.6Periodic safety reports
  7. 6.7Suspension and early termination
  8. 6.8Urgent safety measures
  9. 6.9Post-market clinical follow-up (PMCF)
  10. 6.10Case study: reporting a serious adverse event
  1. 7.1Clinical data management
  2. 7.2Data quality and audits
  3. 7.3Authority inspections
  4. 7.4Statistical analysis and results
  5. 7.5Clinical investigation report
  6. 7.6Publication and transparency
  7. 7.7Integration into the clinical evaluation report
  8. 7.8Archiving and record retention
  9. 7.9Lessons from inspection findings
  10. 7.10Practice: structure of the final investigation report
  1. 8.1Device selection and clinical question
  2. 8.2Study design
  3. 8.3Drafting the CIP
  4. 8.4Documentation for the ethics committee
  5. 8.5Monitoring plan
  6. 8.6Safety management plan
  7. 8.7Data analysis plan
  8. 8.8Timeline and budget
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

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.

Accredited laboratories(EN ISO/IEC 17025) with rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-focused master's thesis:safety case, test plan, compliance dossier and operational limits.
Industry mentorship:faculty with experience in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:a safety-by-design approach, with OT cyber security, DIH and compliance as its pillars.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Device selection and clinical question

Describe the framework for clinical investigation of medical devices.

Study design

Apply the requirements of ISO 14155 throughout the study.

Drafting the CIP

Design a clinical investigation plan using a robust methodology.

Documentation for the ethics committee

Prepare the documentation and authorisation applications.

Monitoring plan

Conduct and monitor an investigation in compliance with GCP.

Career opportunities

Where this takes you

Clinical trial monitor (CRA)Clinical investigation manager for medical devicesClinical affairs specialistClinical trial coordinatorGood clinical practice auditorHead of clinical investigation vigilance
Admissions & scholarships

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.

FAQ

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.

Postgraduate Diploma in ISO 14155 and Good Clinical Practice (GCP)Enrol
Scroll to Top
SEIUM – Institute of Advanced Engineering
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.