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Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

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.

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

What you will be able to do

01

Interpret the clinical evaluation requirements of Regulation (EU) 2017/745.

02

Carry out systematic literature reviews using reproducible methodology.

03

Design clinical investigations that comply with ISO 14155.

04

Apply appropriate statistical methods to studies involving medical devices.

05

Assess diagnostic performance using sensitivity, specificity and ROC curves.

06

Plan post-market clinical follow-up.

07

Write a coherent and traceable clinical evaluation report.

Profile

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.
Standards & tools

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)
Syllabus

8 modules · 800 h

  1. 1.1Requirements of Article 61 and Annex XIV of the MDR
  2. 1.2MEDDEV 2.7/1 rev. 4 guidance
  3. 1.3General safety and performance requirements
  4. 1.4Clinical evaluation plan (CEP)
  5. 1.5Equivalence and its limits
  6. 1.6Sufficient clinical data
  7. 1.7Benefit-risk and state of the art
  8. 1.8Applicable MDCG guidance
  9. 1.9Role of the notified body
  10. 1.10Case study: analysis of a rejected CER
  1. 2.1Search protocol
  2. 2.2Databases: PubMed, Embase and Cochrane
  3. 2.3Inclusion and exclusion criteria
  4. 2.4Methodological quality assessment
  5. 2.5Data extraction
  6. 2.6Risk of bias
  7. 2.7Evidence synthesis
  8. 2.8PRISMA statement
  9. 2.9Unfavourable data and its handling
  10. 2.10Practical: literature search for a stent
  1. 3.1ISO 14155 and good clinical practice
  2. 3.2Pivotal and feasibility studies
  3. 3.3Randomised and non-randomised trials
  4. 3.4Selection of comparator
  5. 3.5Primary and secondary variables
  6. 3.6Eligibility criteria
  7. 3.7Blinding and randomisation
  8. 3.8Ethics committees and authorisations
  9. 3.9Informed consent
  10. 3.10Workshop: draft clinical investigation protocol
  1. 4.1Superiority and non-inferiority hypotheses
  2. 4.2Sample size calculation
  3. 4.3Power and type I error
  4. 4.4Intention-to-treat and per-protocol analysis
  5. 4.5Confidence intervals
  6. 4.6Kaplan-Meier survival analysis
  7. 4.7Logistic and Cox regression
  8. 4.8Missing data and imputation
  9. 4.9Statistical analysis plan (SAP)
  10. 4.10Laboratory: sample size calculation with R
  1. 5.1Sensitivity, specificity and predictive values
  2. 5.2ROC curves and AUC
  3. 5.3Reference standard
  4. 5.4Agreement: kappa and Bland-Altman
  5. 5.5STARD guidelines
  6. 5.6Diagnostic software studies
  7. 5.7Clinical validation of algorithms
  8. 5.8Prevalence and its effect
  9. 5.9Spectrum and verification bias
  10. 5.10Practical: ROC analysis of an algorithm
  1. 6.1PMS plan and PSUR
  2. 6.2PMCF clinical follow-up
  3. 6.3Registries and real-world data
  4. 6.4Incident surveillance
  5. 6.5Trend analysis
  6. 6.6CER update
  7. 6.7SSCP summary
  8. 6.8EUDAMED database
  9. 6.9Risk feedback
  10. 6.10Case study: PMCF plan for an implant
  1. 7.1Structure of the clinical evaluation report
  2. 7.2Device description and indications
  3. 7.3Clinical state of the art
  4. 7.4Analysis of own and literature data
  5. 7.5Conclusions on safety and performance
  6. 7.6Consistency with IFU and risk management
  7. 7.7Qualification of evaluators
  8. 7.8Response to non-conformities
  9. 7.9Quality of technical writing
  10. 7.10Workshop: drafting the state-of-the-art section
  1. 8.1Device selection
  2. 8.2Clinical evaluation plan
  3. 8.3Systematic review
  4. 8.4Complementary study design
  5. 8.5Statistical analysis plan
  6. 8.6PMCF plan
  7. 8.7Writing the CER
  8. 8.8Self-assessment against requirements
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

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.

Accreditable laboratories(EN ISO/IEC 17025) with a 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 mentoring:instructors 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 cyber-OT, DIH and compliance as core 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

Interpret the clinical evaluation requirements of Regulation (EU) 2017/745.

Clinical evaluation plan

Carry out systematic literature reviews using reproducible methodology.

Systematic review

Design clinical investigations that comply with ISO 14155.

Complementary study design

Apply appropriate statistical methods to studies involving medical devices.

Statistical analysis plan

Assess diagnostic performance using sensitivity, specificity and ROC curves.

Career opportunities

Where this takes you

Clinical evaluation specialistMedical writerBiostatisticianRegulatory affairs managerClinical investigation managerPost-market follow-up manager
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.

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FAQ

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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