Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Postgraduate Diploma in Outcome Validation and Patient Follow-Up

Online 800-hour Postgraduate Diploma in Outcome Validation and Patient Follow-Up. 8 modules covering ISO 14155 (clinical investigation of medical devices), Regulation (EU) 2017/745 (medical devices), and a dedicated tutor, with enrolment open.

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

Postgraduate Diploma in Outcome Validation and Patient Follow-Up — studying from Singapore

Singapore's healthcare and medtech sectors are supported by the Health Sciences Authority, which regulates medical devices, and the Agency for Science, Technology and Research, which funds biomedical research. Engineers work on medical device design, biomechanics, wearable sensors and occupational safety systems. The Ministry of Manpower oversees workplace safety standards. Employers include medical device manufacturers, hospitals and research institutes in the one-north and Biopolis precincts.

Fees for Singapore: S$1,560 (Singapore dollar), with instalments and employer sponsorship available.

Relevant bodies in Singapore

  • Health Sciences Authority (HSA)
  • Ministry of Manpower (MOM)
  • Agency for Science, Technology and Research (A*STAR)
  • Biomedical Engineering Society Singapore

Typical roles

  • Medical Device Engineer
  • Biomechanics Engineer
  • Wearables Engineer
  • Occupational Safety Engineer

Questions from Singapore

Will this qualification be recognised by professional bodies in Singapore?

SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body in Singapore. Professional engineering registration in Singapore is handled through the Professional Engineers Board (PEB), which registers Professional Engineers under the Professional Engineers Act. Recognition of a private qualification is ultimately decided by employers or the relevant body, so check with them before enrolling.

How might this training be used by employers in Singapore?

Employers in Singapore's healthtech, medical device, wearables and workplace safety sectors may value specialist skills in biomechanics and operational safety. Whether they count an online private qualification toward a role is up to each employer. Many firms look at portfolios, project work and experience alongside any certificate, so the final project can be a useful piece of evidence to show them.

Can I study this alongside a full-time job, and can my employer help fund it?

The programme is 100% online and taught in English, so it suits working professionals, though the workload is significant: master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours. Fees can be paid in instalments, and employer sponsorship is possible. Many Singapore employers fund job-related training, so it is worth asking your HR or training department early.

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Learning outcomes

What you will be able to do

01

Define clinical, functional and patient-perceived outcomes relevant to each intervention.

02

Select measurement instruments that are valid, reliable and sensitive to change.

03

Design interoperable and sustainable patient follow-up systems.

04

Manage real-world data with quality and completeness controls.

05

Analyse outcomes adjusting for risk and confounding factors.

06

Validate and audit outcomes before their clinical or regulatory use.

07

Develop an outcome follow-up project for a service or product.

Profile

Who it's for

  • Health outcomes analyst who wants to specialise in Outcome Validation and Patient Follow-Up.
  • Clinical records manager who wants to specialise in Outcome Validation and Patient Follow-Up.
  • Researcher in patient-reported outcomes who wants to specialise in Outcome Validation and Patient Follow-Up.
  • Real-world evidence specialist who wants to specialise in Outcome Validation and Patient Follow-Up.
  • Clinical quality manager who wants to specialise in Outcome Validation and Patient Follow-Up.
  • Health technology assessment consultant who wants to specialise in Outcome Validation and Patient Follow-Up.
  • Graduates in engineering or sciences seeking to enter public and private healthcare.
Standards & tools

What you'll work with

  • ISO 14155 (clinical investigation of medical devices)
  • Regulation (EU) 2017/745 (medical devices)
  • COSMIN standard (quality of measurement instruments)
  • ICHOM Standard Sets
  • HL7 FHIR
  • Regulation (EU) 2016/679 (GDPR)
  • ISO 13485
Syllabus

8 modules · 800 h

  1. 1.1Clinical, PROM and PREM outcomes
  2. 1.2Value-based care
  3. 1.3ICHOM standard sets
  4. 1.4Donabedian structure, process and outcome
  5. 1.5Intermediate and final outcomes
  6. 1.6The patient perspective
  7. 1.7Variation in clinical practice
  8. 1.8Quality of care indicators
  9. 1.9Using outcomes in management
  10. 1.10Case study: selecting outcomes for hip arthroplasty
  1. 2.1Psychometric properties according to COSMIN
  2. 2.2Content and construct validity
  3. 2.3Reliability and measurement error
  4. 2.4Responsiveness to change
  5. 2.5Cross-cultural adaptation of questionnaires
  6. 2.6PROMIS and adaptive tests
  7. 2.7Minimal clinically important difference
  8. 2.8Generic instruments: EQ-5D and SF-36
  9. 2.9Disease-specific instruments
  10. 2.10Practice: psychometric evaluation of a questionnaire
  1. 3.1Designing follow-up cohorts
  2. 3.2Patient clinical registries
  3. 3.3Follow-up schedule
  4. 3.4Electronic capture of PROMs
  5. 3.5Integration with the clinical record
  6. 3.6Retention and loss to follow-up
  7. 3.7Reminders and contact channels
  8. 3.8Monitoring complications and readmissions
  9. 3.9Quality of collected data
  10. 3.10Workshop: designing a postoperative follow-up pathway
  1. 4.1Sources: EHR, registries and insurers
  2. 4.2OMOP common data model
  3. 4.3Data quality and completeness
  4. 4.4Record linkage
  5. 4.5Biases in observational studies
  6. 4.6Target trial emulation
  7. 4.7Real-world evidence in regulatory decisions
  8. 4.8Data protection in secondary use
  9. 4.9OHDSI community tools
  10. 4.10Practice: querying a sample OMOP database
  1. 5.1Longitudinal analysis of repeated measures
  2. 5.2Survival analysis
  3. 5.3Risk adjustment
  4. 5.4Propensity scores
  5. 5.5Missing data in PROMs
  6. 5.6Hierarchical models by centre
  7. 5.7Individual interpretation of change
  8. 5.8Visualisation of trajectories
  9. 5.9Responder analysis
  10. 5.10Laboratory: PROM analysis with mixed models
  1. 6.1Clinical audit and the improvement cycle
  2. 6.2Comparison between centres and benchmarking
  3. 6.3Funnel plots
  4. 6.4CUSUM and VLAD charts
  5. 6.5Detection of outlier centres
  6. 6.6Source data verification
  7. 6.7Transparency and publication of results
  8. 6.8Risks of unadjusted comparison
  9. 6.9Peer review of outcomes
  10. 6.10Case study: auditing cardiac surgery outcomes
  1. 7.1Feedback to professionals
  2. 7.2Shared decision-making
  3. 7.3PROMs in the consultation
  4. 7.4Pay for performance
  5. 7.5Value-based contracts
  6. 7.6Continuous process improvement
  7. 7.7Patient involvement
  8. 7.8Outcome dashboards
  9. 7.9Implementation barriers
  10. 7.10Workshop: outcome dashboard for a service
  1. 8.1Clinical condition and population
  2. 8.2Outcome set
  3. 8.3Selection of instruments
  4. 8.4Follow-up pathway
  5. 8.5Analysis plan
  6. 8.6Data validation
  7. 8.7Plan for using outcomes
  8. 8.8Success indicators
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

How you'll learn

Fully 100% online training on the SEIUM Institute campus, with downloadable material, recorded classes and a dedicated technical tutor. There are no fixed timetables: students progress at their own pace within the intake, which makes it possible to combine the programme with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is R, SPSS, REDCap, Python (pandas), Power BI, in free, academic or evaluation versions. Trials are studied using real procedures for the psychometric validation of outcome questionnaires, analysis of real-world data records, and auditing the quality of follow-up data. Assessment is continuous by module, plus the final integrating project.

Accreditable laboratories(EN ISO/IEC 17025) with a rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-oriented final project:safety case, test plan, compliance dossier and operational limits.
Industry-mentored:lecturers with a track record in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:safety-by-design approach, ciber-OT, DIH and compliance as pillars.
Capstone project

Build it end to end

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

Clinical condition and population

Define clinical, functional and patient-perceived outcomes relevant to each intervention.

Outcome set

Select measurement instruments that are valid, reliable and sensitive to change.

Selection of instruments

Design interoperable and sustainable patient follow-up systems.

Follow-up pathway

Manage real-world data with quality and completeness controls.

Analysis plan

Analyse outcomes adjusting for risk and confounding factors.

Career opportunities

Where this takes you

Health outcomes analystClinical records managerResearcher in patient-reported outcomesReal-world evidence specialistClinical quality managerHealth technology assessment consultant
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 reading.

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 total 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 R, SPSS, REDCap, Python (pandas) and Power BI. Free, academic or evaluation versions are used, and the tutor indicates the open-source alternative where one exists.

A SEIUM Institute own diploma upon passing the continuous assessment and the integrating project. This is in-house training, not an official Ministry of Education qualification.

Yes. Modules passed in a course or postgraduate diploma in the same area are credited towards the advanced programme. Check the credit transfer policy when you enrol.

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