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.
Postgraduate Diploma in Post-Market Surveillance and PMCF — studying from India
India's medical device and healthcare technology sector is growing, with manufacturing and design clusters in Hyderabad, Bengaluru, Ahmedabad and the National Capital Region. Regulation of medical devices is handled by the Central Drugs Standard Control Organisation under the Central Drugs Standards Control Organisation framework, and the Bureau of Indian Standards issues relevant norms. Hospitals, device makers and rehabilitation technology firms create demand for biomechanics and wearables expertise. Operational safety and occupational health are overseen through the Directorate General Factory Advice Service and Labour Institutes, making this area relevant to industrial and healthcare engineers alike.
Fees for India: ₹95,000 (Indian Rupee), with instalments and employer sponsorship available.
Relevant bodies in India
Typical roles
Questions from India
Will this programme be recognised by professional bodies in India for health and biomechanics work?
SEIUM's qualifications are private qualifications, not official state degrees, and they are not accredited by any national body in India. Recognition is decided by employers and by the relevant body in each case. Medical devices fall under CDSCO, and professional engineering recognition in India is handled by bodies such as the Institution of Engineers (India). Please check with them directly before relying on the qualification.
Which employers in India use skills in biomechanics, wearables and operational safety?
Typical employers include medical device companies, hospitals with engineering departments, sports science organisations, and firms making wearable or industrial safety products. Hiring depends on the employer's own criteria and on your existing experience. The qualification may help you show specialist knowledge, but whether a particular employer values it is for that employer to decide.
Can I study this alongside a full-time job in India, and does it need English?
The programme is 100% online and taught in English, so you need a working level of English. Time zone is not a barrier because the course is asynchronous, and you can study from anywhere in India without a student visa. Workload depends on the programme length, and each student is assigned a technical tutor for support. Many people fund it through employer sponsorship or pay in instalments.
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
Describe the post-market surveillance system required by the MDR.
Manage serious incidents, field safety corrective actions and notifications to authorities.
Relate clinical evaluation to post-market clinical follow-up.
Select PMCF methods: registries, surveys, studies and literature review.
Analyse post-market data and identify trends.
Integrate findings into risk management and the quality system.
Prepare a surveillance and PMCF plan for a medical device.
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.
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)
8 modules · 800 h
1.1Requirements of Chapter VII of the MDR1.2PMS system proportionate to risk1.3Post-market surveillance plan1.4PMS report and PSUR1.5Proactive and reactive data sources1.6Relationship with risk management1.7Role of the person responsible for regulatory compliance1.8EUDAMED database1.9FDA requirements1.10Case study: PMS plan for a class IIb product
2.1Serious incidents and reporting deadlines2.2MIR reporting form2.3Field safety corrective actions (FSCA)2.4Field safety notices (FSN)2.5Trend reports2.6MDCG 2023-3 guidance2.7Incident investigation2.8Communication with authorities2.9MDR reporting to the FDA2.10Workshop: completing an MIR report
3.1Clinical evaluation under Article 613.2Clinical evaluation report (CER)3.3Concept of PMCF3.4PMCF plan according to MDCG 2020-73.5PMCF report according to MDCG 2020-83.6Justification for the absence of PMCF3.7Equivalence and third-party data3.8Legacy devices and clinical data3.9Summary of safety and clinical performance (SSCP)3.10Practice: PMCF plan for an orthopaedic implant
4.1Observational follow-up studies4.2Product registries4.3User surveys4.4Systematic literature review4.5Studies according to ISO 141554.6Real-world data4.7PROMs and patient follow-up4.8Sample size in PMCF4.9Risks of bias4.10Case study: designing an implant registry
5.1Complaint trend analysis5.2Incident rates and denominators5.3Statistical process control5.4Implant survival analysis5.5Signal detection5.6MAUDE database review5.7Text mining of complaints5.8Updating the benefit-risk analysis5.9Updating the risk file5.10Laboratory: signal analysis in complaint data
6.1Complaints under ISO 134856.2CAPA arising from surveillance6.3Updating technical documentation6.4Feedback to design6.5ISO/TR 20416 for surveillance6.6PMS system indicators6.7Notified body audits6.8Distributor responsibilities6.9PMS management software6.10Workshop: complaints-to-CAPA workflow
7.1Software and SaMD7.2AI products and continuous learning7.3In vitro diagnostic devices7.4Combination products with medicinal products7.5Class III implants7.6Custom-made and personalised devices7.7Reprocessed single-use devices7.8Management of product recalls7.9Lessons from PIP breast implants7.10Case study: PMS of AI software
8.1Product description8.2Drafting the PMS plan8.3Data sources8.4Drafting the PMCF plan8.5Analysis plan8.6Surveillance procedure8.7Indicators and trends8.8PSUR templates8.9Report 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 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.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe the post-market surveillance system required by the MDR.
Manage serious incidents, field safety corrective actions and notifications to authorities.
Relate clinical evaluation to post-market clinical follow-up.
Select PMCF methods: registries, surveys, studies and literature review.
Analyse post-market data and identify trends.
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 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 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.
Related programmes
Postgraduate Diploma in Accessibility Audits and Continuous Improvement
Online 800-hour Postgraduate Diploma in Accessibility Audits and Continuous Improvement. 8 modules covering UNE-EN 301549 (accessibility requirements for ICT products and services), WCAG 2.2 and axe…
Diploma in Workshop Network Operations: Times, Warranty and KPIs
Online postgraduate diploma of 800 hours in workshop network operations — labour times, warranty and KPIs. 8 modules covering fundamentals, the regulatory framework (MDR, ISO 13485,…
Postgraduate Diploma in Hand-Arm and Whole-Body Vibration Exposure (ISO 5349/2631)
Online Postgraduate Diploma of 800 hours in Hand-Arm and Whole-Body Vibration Exposure (ISO 5349/2631). 8 modules covering ISO 5349-1 (hand-arm vibration, general requirements), ISO 5349-2 (hand-arm…
More in Health, Biomechanics, Wearables & Operational Safety
All Health, Biomechanics, Wearables & Operational Safety programmes → · How to apply · Fees & financing · Scholarships