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Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Postgraduate Diploma in Post-Market Surveillance and PMCF

Online 800-hour Postgraduate Diploma in Post-Market Surveillance and PMCF. 8 modules covering Regulation (EU) 2017/745 (medical devices, arts. 83 to 92), MDCG 2020-7 (PMCF plan template) and EUDAMED. 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

Describe the post-market surveillance system required by the MDR.

02

Manage serious incidents, field safety corrective actions and notifications to authorities.

03

Relate clinical evaluation to post-market clinical follow-up.

04

Select PMCF methods: registries, surveys, studies and literature review.

05

Analyse post-market data and identify trends.

06

Integrate findings into risk management and the quality system.

07

Prepare a surveillance and PMCF plan for a medical device.

Profile

Who it's for

  • Post-market surveillance specialist looking to specialise in Post-Market Surveillance and PMCF.
  • Medical device surveillance manager looking to specialise in Post-Market Surveillance and PMCF.
  • Clinical evaluator looking to specialise in Post-Market Surveillance and PMCF.
  • Regulatory affairs technician looking to specialise in Post-Market Surveillance and PMCF.
  • PMCF study manager looking to specialise in Post-Market Surveillance and PMCF.
  • Regulatory compliance officer (PRRC) looking to specialise in Post-Market Surveillance and PMCF.
  • Engineering or science graduates seeking to enter the medical device industry.
Standards & tools

What you'll work with

  • Regulation (EU) 2017/745 (medical devices, arts. 83 to 92)
  • MDCG 2020-7 (PMCF plan template)
  • MDCG 2020-8 (PMCF evaluation report template)
  • ISO/TR 20416 (post-market surveillance)
  • ISO 14155 (clinical investigation)
  • ISO 13485
  • ISO 14971 (risk management)
Syllabus

8 modules · 800 h

  1. 1.1Requirements of Chapter VII of the MDR
  2. 1.2PMS system proportionate to risk
  3. 1.3Post-market surveillance plan
  4. 1.4PMS report and PSUR
  5. 1.5Proactive and reactive data sources
  6. 1.6Relationship with risk management
  7. 1.7Role of the person responsible for regulatory compliance
  8. 1.8EUDAMED database
  9. 1.9FDA requirements
  10. 1.10Case study: PMS plan for a class IIb product
  1. 2.1Serious incidents and reporting deadlines
  2. 2.2MIR reporting form
  3. 2.3Field safety corrective actions (FSCA)
  4. 2.4Field safety notices (FSN)
  5. 2.5Trend reports
  6. 2.6MDCG 2023-3 guidance
  7. 2.7Incident investigation
  8. 2.8Communication with authorities
  9. 2.9MDR reporting to the FDA
  10. 2.10Workshop: completing an MIR report
  1. 3.1Clinical evaluation under Article 61
  2. 3.2Clinical evaluation report (CER)
  3. 3.3Concept of PMCF
  4. 3.4PMCF plan according to MDCG 2020-7
  5. 3.5PMCF report according to MDCG 2020-8
  6. 3.6Justification for the absence of PMCF
  7. 3.7Equivalence and third-party data
  8. 3.8Legacy devices and clinical data
  9. 3.9Summary of safety and clinical performance (SSCP)
  10. 3.10Practice: PMCF plan for an orthopaedic implant
  1. 4.1Observational follow-up studies
  2. 4.2Product registries
  3. 4.3User surveys
  4. 4.4Systematic literature review
  5. 4.5Studies according to ISO 14155
  6. 4.6Real-world data
  7. 4.7PROMs and patient follow-up
  8. 4.8Sample size in PMCF
  9. 4.9Risks of bias
  10. 4.10Case study: designing an implant registry
  1. 5.1Complaint trend analysis
  2. 5.2Incident rates and denominators
  3. 5.3Statistical process control
  4. 5.4Implant survival analysis
  5. 5.5Signal detection
  6. 5.6MAUDE database review
  7. 5.7Text mining of complaints
  8. 5.8Updating the benefit-risk analysis
  9. 5.9Updating the risk file
  10. 5.10Laboratory: signal analysis in complaint data
  1. 6.1Complaints under ISO 13485
  2. 6.2CAPA arising from surveillance
  3. 6.3Updating technical documentation
  4. 6.4Feedback to design
  5. 6.5ISO/TR 20416 for surveillance
  6. 6.6PMS system indicators
  7. 6.7Notified body audits
  8. 6.8Distributor responsibilities
  9. 6.9PMS management software
  10. 6.10Workshop: complaints-to-CAPA workflow
  1. 7.1Software and SaMD
  2. 7.2AI products and continuous learning
  3. 7.3In vitro diagnostic devices
  4. 7.4Combination products with medicinal products
  5. 7.5Class III implants
  6. 7.6Custom-made and personalised devices
  7. 7.7Reprocessed single-use devices
  8. 7.8Management of product recalls
  9. 7.9Lessons from PIP breast implants
  10. 7.10Case study: PMS of AI software
  1. 8.1Product description
  2. 8.2Drafting the PMS plan
  3. 8.3Data sources
  4. 8.4Drafting the PMCF plan
  5. 8.5Analysis plan
  6. 8.6Surveillance procedure
  7. 8.7Indicators and trends
  8. 8.8PSUR templates
  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 enrolment period, making it possible to combine with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is EUDAMED, R, REDCap, Python (pandas), advanced Excel, in free, academic or evaluation versions. Case studies are based on real procedures for drafting PMS and PMCF plans, analysis of incident and complaint trends, and drafting of PSUR reports. 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-oriented Master's Thesis:safety case, test plan, compliance dossier and operational limits.
Industry mentoring: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:safety-by-design approach, ciber-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.

Product description

Describe the post-market surveillance system required by the MDR.

Drafting the PMS plan

Manage serious incidents, field safety corrective actions and notifications to authorities.

Data sources

Relate clinical evaluation to post-market clinical follow-up.

Drafting the PMCF plan

Select PMCF methods: registries, surveys, studies and literature review.

Analysis plan

Analyse post-market data and identify trends.

Career opportunities

Where this takes you

Post-market surveillance specialistMedical device surveillance managerClinical evaluatorRegulatory affairs technicianPMCF study managerRegulatory compliance officer (PRRC)
Admissions & scholarships

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 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 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 EUDAMED, R, REDCap, Python (pandas) and advanced Excel. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.

A SEIUM diploma upon passing the continuous assessment and the integrating project. This 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 credited towards the higher programme. Check the credit recognition policy when you enrol.

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