Postgraduate Diploma in Study Design, Statistics and CER Dossier
Online 800-hour Postgraduate Diploma in Study Design, Statistics and CER Dossier. 8 modules with Regulation (EU) 2017/745 (MDR), MDCG 2020-13 (clinical evaluation report) and R. Assigned tutor and open enrolment.
Postgraduate Diploma in Study Design, Statistics and CER Dossier — 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$1,280 (Singapore dollar), with instalments and employer sponsorship available.
Relevant bodies in Singapore
Typical roles
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.
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.
What you will be able to do
Interpret the clinical evaluation requirements of Regulation (EU) 2017/745.
Carry out systematic literature reviews using reproducible methodology.
Design clinical investigations that comply with ISO 14155.
Apply appropriate statistical methods to studies involving medical devices.
Assess diagnostic performance using sensitivity, specificity and ROC curves.
Plan post-market clinical follow-up.
Write a coherent and traceable clinical evaluation report.
Who it's for
- Clinical evaluation specialist who wants to specialise in Study Design, Statistics and CER Dossier.
- Medical writer who wants to specialise in Study Design, Statistics and CER Dossier.
- Biostatistician who wants to specialise in Study Design, Statistics and CER Dossier.
- Regulatory affairs manager who wants to specialise in Study Design, Statistics and CER Dossier.
- Clinical investigation manager who wants to specialise in Study Design, Statistics and CER Dossier.
- Post-market follow-up manager who wants to specialise in Study Design, Statistics and CER Dossier.
- Engineering or science graduates looking to enter health technology.
What you'll work with
- Regulation (EU) 2017/745 (MDR)
- MDCG 2020-13 (clinical evaluation report)
- ISO 14155 (clinical investigation of medical devices)
- MEDDEV 2.7/1 rev. 4 (clinical evaluation)
- MDCG 2020-7 (post-market clinical follow-up plan)
- PRISMA 2020 (systematic reviews)
- STARD 2015 (diagnostic accuracy studies)
8 modules · 800 h
1.1Requirements of Article 61 and Annex XIV of the MDR1.2MEDDEV 2.7/1 rev. 4 guidance1.3General safety and performance requirements1.4Clinical evaluation plan (CEP)1.5Equivalence and its limits1.6Sufficient clinical data1.7Benefit-risk and state of the art1.8Applicable MDCG guidance1.9Role of the notified body1.10Case study: analysis of a rejected CER
2.1Search protocol2.2Databases: PubMed, Embase and Cochrane2.3Inclusion and exclusion criteria2.4Methodological quality assessment2.5Data extraction2.6Risk of bias2.7Evidence synthesis2.8PRISMA statement2.9Unfavourable data and its handling2.10Practical: literature search for a stent
3.1ISO 14155 and good clinical practice3.2Pivotal and feasibility studies3.3Randomised and non-randomised trials3.4Selection of comparator3.5Primary and secondary variables3.6Eligibility criteria3.7Blinding and randomisation3.8Ethics committees and authorisations3.9Informed consent3.10Workshop: draft clinical investigation protocol
4.1Superiority and non-inferiority hypotheses4.2Sample size calculation4.3Power and type I error4.4Intention-to-treat and per-protocol analysis4.5Confidence intervals4.6Kaplan-Meier survival analysis4.7Logistic and Cox regression4.8Missing data and imputation4.9Statistical analysis plan (SAP)4.10Laboratory: sample size calculation with R
5.1Sensitivity, specificity and predictive values5.2ROC curves and AUC5.3Reference standard5.4Agreement: kappa and Bland-Altman5.5STARD guidelines5.6Diagnostic software studies5.7Clinical validation of algorithms5.8Prevalence and its effect5.9Spectrum and verification bias5.10Practical: ROC analysis of an algorithm
6.1PMS plan and PSUR6.2PMCF clinical follow-up6.3Registries and real-world data6.4Incident surveillance6.5Trend analysis6.6CER update6.7SSCP summary6.8EUDAMED database6.9Risk feedback6.10Case study: PMCF plan for an implant
7.1Structure of the clinical evaluation report7.2Device description and indications7.3Clinical state of the art7.4Analysis of own and literature data7.5Conclusions on safety and performance7.6Consistency with IFU and risk management7.7Qualification of evaluators7.8Response to non-conformities7.9Quality of technical writing7.10Workshop: drafting the state-of-the-art section
8.1Device selection8.2Clinical evaluation plan8.3Systematic review8.4Complementary study design8.5Statistical analysis plan8.6PMCF plan8.7Writing the CER8.8Self-assessment against requirements8.9Report and presentation8.10Final review with the tutor
How you'll learn
Training is 100 % online on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the intake period, 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 R, SAS, IBM SPSS Statistics, Covidence, G*Power, in free, academic or evaluation versions. Trials are studied through real procedures for systematic clinical literature review, statistical analysis of clinical investigation data, and the writing and review of CER dossiers. 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.
Interpret the clinical evaluation requirements of Regulation (EU) 2017/745.
Carry out systematic literature reviews using reproducible methodology.
Design clinical investigations that comply with ISO 14155.
Apply appropriate statistical methods to studies involving medical devices.
Assess diagnostic performance using sensitivity, specificity and ROC curves.
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 consists of 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with full-time work.
You will work with R, SAS, IBM SPSS Statistics, Covidence, G*Power. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
A 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 are recognised towards the higher programme. Check the recognition policy when you enrol.
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