Postgraduate Diploma in Wearable Devices for Clinical Research
800-hour online Postgraduate Diploma in Wearable Devices for Clinical Research. 8 modules covering ISO 14155 (clinical investigation of medical devices), ICH E6 (good clinical practice) and REDCap. Assigned tutor and open enrolment.
Postgraduate Diploma in Wearable Devices for Clinical Research — 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 24 000 (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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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
Define digital biomarkers and their contexts of use.
Select wearable devices suitable for a clinical study.
Apply the V3 framework for verification, analytical validation and clinical validation.
Design clinical validation studies of digital measures.
Integrate wearables into decentralised clinical trials.
Process and analyse sensor data using reproducible methods.
Meet regulatory, ethical and privacy requirements.
Who it's for
- Digital biomarker specialist who wants to specialise in Wearable Devices for Clinical Research.
- Clinical trial manager who wants to specialise in Wearable Devices for Clinical Research.
- Clinical data scientist who wants to specialise in Wearable Devices for Clinical Research.
- Wearables validation engineer who wants to specialise in Wearable Devices for Clinical Research.
- Digital clinical operations manager who wants to specialise in Wearable Devices for Clinical Research.
- Biostatistician who wants to specialise in Wearable Devices for Clinical Research.
- Engineering or science graduates looking to enter the pharmaceutical industry.
What you'll work with
- ISO 14155 (clinical investigation of medical devices)
- ICH E6 (good clinical practice)
- Regulation (EU) 2017/745 (MDR)
- 21 CFR Part 11 (electronic records)
- FDA guidance on digital health technologies for remote data acquisition in clinical investigations (2023)
- ISO 14971 (risk management)
- Regulation (EU) 2016/679 (GDPR)
8 modules · 800 h
1.1Definition of digital biomarker1.2Digital outcome measures1.3V3 framework for verification and validation1.4Context of use1.5Heart rate, activity and sleep1.6Gait and mobility1.7Voice and cognition biomarkers1.8Accepted digital endpoints1.9DiMe initiatives and consortia1.10Case study: gait speed endpoint accepted by the EMA
2.1Technical selection criteria2.2Consumer grade versus medical grade2.3Access to raw data2.4Battery life and adherence2.5Body placement2.6Firmware and version control2.7Availability and logistics2.8Supplier evaluation2.9Cost per participant2.10Practical: selection matrix for a Parkinson's trial
3.1Sensor verification3.2Analytical validation of algorithms3.3Comparison with reference3.4Bland-Altman and agreement3.5Test-retest reliability3.6Validation in the target population3.7Bias by skin tone and age3.8Real-world conditions3.9Technical documentation3.10Laboratory: validation of a pedometer against video
4.1Construct validity4.2Responsiveness to change4.3Minimal clinically important difference4.4Correlation with clinical scales4.5Observational studies4.6Intra- and inter-subject variability4.7Patient-level significance4.8Qualification with the EMA4.9FDA guidance on digital health technologies4.10Workshop: responsiveness-to-change analysis
5.1Protocol and digital endpoints5.2Participant training5.3Adherence and wear time5.4Device management and shipping5.5Data platforms5.6Integration with EDC5.7Data quality monitoring5.8Missing data5.9Safety and adverse events5.10Case study: operational plan for a wearables trial
6.1Preprocessing of accelerometry signals6.2Wear-time detection6.3Activity and sleep algorithms6.4Machine learning6.5Daily and weekly aggregation6.6Longitudinal analysis with mixed models6.7Pipeline reproducibility6.8Data standards6.9Visualisation6.10Laboratory: actigraphy pipeline with GGIR
7.1Wearables as medical devices7.2Research data and GDPR7.3Consent for continuous data7.4International transfers7.5Cybersecurity7.6Data ownership7.7Equity and the digital divide7.8Ethics committees7.9Return of results7.10Practical: data protection impact assessment
8.1Clinical question8.2Selection of the digital biomarker8.3Device selection8.4Validation plan8.5Study design8.6Data and analysis plan8.7Ethical and regulatory analysis8.8Budget8.9Report 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 REDCap, R, Python (pandas), MATLAB, ActiLife (ActiGraph), in free, academic or evaluation versions. Trials are studied using real analytical validation procedures against a reference device, pilot adherence studies with volunteers and decentralised clinical trial protocols. Assessment is continuous by module, plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Define digital biomarkers and their contexts of use.
Select wearable devices suitable for a clinical study.
Apply the V3 framework for verification, analytical validation and clinical validation.
Design clinical validation studies of digital measures.
Integrate wearables into decentralised clinical trials.
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 the reading of technical regulations.
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 totals 800 hours, 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, R, Python (pandas), MATLAB, ActiLife (ActiGraph). Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An own SEIUM diploma upon passing the continuous assessment and the integrative project. It is in-house training, not an official qualification from the Ministry of Education.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised towards the higher programme. Check the recognition policy when you enrol.
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