Medical Device and IVD Post-Market Surveillance Course

Name: Medical Device and IVD Post-Market Surveillance Training Course
Availability: InStock

Build traceable PMS, vigilance, trend, corrective-action and periodic-reporting controls for medical device and IVD teams.

Medical Device and IVD Post-Market Surveillance Course

At a glance

Duration: 1 Week
Format: Classroom
Cities: Chicago, Istanbul, Phuket, Barcelona, Amsterdam, Manama and more
Next session: 1 – 5 November 2026, Chicago
Average fee: 5,750 €

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Medical Device and IVD Post-Market Surveillance Training Course

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Overview

Medical device and IVD post-market surveillance is an advanced one-week course for quality, regulatory, vigilance and safety professionals who need a Post-Market Surveillance and Vigilance Control File. The course addresses fragmented evidence through PMS planning, complaint intake, signal and trend analysis, reportability decisions, serious-incident escalation, field safety corrective action, PSUR and PMPF interfaces, governance and audit readiness. Agile Leaders Training Center places medical device and IVD post-market surveillance within lifecycle safety management.

Who Should Attend

Teams responsible for medical-device and IVD quality-system evidence
Functions responsible for regulatory reporting and authority communication
Personnel responsible for PMS, vigilance and safety signal review
Teams responsible for complaint handling and investigation records
Clinical and performance specialists responsible for post-market evidence
Managers responsible for escalation, governance and audit readiness

The course assumes participants already work with regulated-device quality or safety records and leaves out ISO 13485 foundations, design controls and premarket submission preparation.

Departments and Industries

The course supports departments and organizations that manufacture, monitor or support medical devices and IVDs after market placement.

Medical-device and IVD manufacturers
Regulatory affairs and quality assurance functions
Complaint handling and customer-quality teams
Clinical, safety and performance-evaluation functions
Distribution and economic-operator quality teams
Testing, laboratory and healthcare-technology organizations

Learning Objectives

By the end of this course, participants will be able to:

Apply risk-proportionate PMS planning and governance controls
Use complaint, incident and signal intake taxonomies
Analyze trends, thresholds and reportability evidence
Build serious-incident and FSCA decision records
Prioritize PSUR, PMPF and risk-management updates
Evaluate data quality, escalation and audit readiness

Course Agenda

Day 1: PMS System Architecture

MDR and IVDR PMS Obligation Map
Risk-Proportionate PMS System Design
PMS Plan Evidence-Source Matrix
Lifecycle Document Interface Map
PMS Governance and Responsibility Chart

Day 2: Complaints, Incidents and Signals

Complaint Intake and Coding Taxonomy
Device Event Investigation Record
Serious-Incident Assessment Decision Tree
Signal Detection and Validation Log
Data Quality and Case-Completeness Checklist

Day 3: Vigilance and Corrective Action

Reportability Decision and Rationale Template
Vigilance Escalation Workflow
Trend Reporting Threshold Method
Field Safety Corrective Action Decision Pack
Field Safety Notice Review Checklist

Day 4: Periodic Evidence and Governance

PMS Report and PSUR Content Matrix
PMPF and Post-Market Evidence Interface
Benefit-Risk and Risk-Management Update Map
Management Review PMS Dashboard
Audit Trail and Inspection-Readiness File

Day 5: PMS and Vigilance Practice

Suggested Exercise: Complaint-to-Signal Case Review
Suggested Exercise: Serious-Incident Reportability Decision
Suggested Exercise: Trend Threshold and Escalation Review
Suggested Exercise: FSCA and Periodic Report Evidence Check
Capstone Exercise: Post-Market Surveillance and Vigilance Control File

Practical Exercises

The course uses suggested activities based on medical-device, IVD, laboratory and distribution cases.

Suggested activity: map PMS data sources to risk, performance and corrective-action decisions.
Suggested activity: assess a complaint cluster for signal validation, trend reporting and escalation.
Suggested activity: document a reportability decision and proposed field safety corrective action.
Suggested activity: audit a periodic safety file for traceability, interfaces and missing evidence.

FAQs

Who does the medical device and IVD post-market surveillance course suit, and what does it assume?

The course suits experienced quality, regulatory, vigilance, complaint and safety personnel and assumes familiarity with regulated-device records, risk evidence and organizational quality processes.

How does medical device and IVD post-market surveillance differ from ISO 13485 foundation training?

Post-market surveillance focuses on active market evidence, incidents, signals, trends, periodic reporting and corrective action, while foundation training explains broader quality-management requirements.

What evidence belongs in a medical device PMS plan?

A PMS plan organizes proactive and reactive data sources, analysis methods, indicators, responsibilities, reporting outputs, document interfaces and routes for preventive or corrective action.

How are vigilance reportability decisions documented?

Reportability decisions record event facts, seriousness, device relationship, applicable criteria, uncertainty, escalation, reporting action and the evidence supporting the rationale.

How do PSUR and PMPF connect to IVD post-market surveillance?

PSUR and PMPF outputs connect periodic safety and performance evidence with trend evaluation, benefit-risk review, risk management and updates to lifecycle documentation.

Conclusion

Participants leave with a Post-Market Surveillance and Vigilance Control File containing PMS architecture, intake taxonomy, signal logs, reportability records, trend methods, FSCA evidence and periodic-report interfaces. The file makes safety decisions and document updates traceable. It supports governance across quality, regulatory, clinical, performance and management functions.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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Showing 21-40 of 75 events

Location	Dates	Duration	Mode	Price
Marbella	Week 05, 2027 7 – 11 February 2027	1 Week	Onsite	€5,700
Singapore	Week 07, 2027 15 – 19 February 2027	1 Week	Onsite	€5,700
Vienna	Week 08, 2027 22 – 26 February 2027	1 Week	Onsite	€5,700
Kuala Lumpur	Week 09, 2027 1 – 5 March 2027	1 Week	Onsite	€5,200
Baku	Week 09, 2027 1 – 5 March 2027	1 Week	Onsite	€5,000
Toronto	Week 09, 2027 7 – 11 March 2027	1 Week	Onsite	€12,000
Paris	Week 10, 2027 8 – 12 March 2027	1 Week	Onsite	€5,700
Cape town	Week 10, 2027 14 – 18 March 2027	1 Week	Onsite	€4,500
Zoom	Week 12, 2027 22 – 26 March 2027	1 Week	Online	€1,500
Amsterdam	Week 13, 2027 29 March – 2 April 2027	1 Week	Onsite	€5,700
Rome	Week 14, 2027 5 – 9 April 2027	1 Week	Onsite	€5,700
Tokyo	Week 15, 2027 12 – 16 April 2027	1 Week	Onsite	€10,000
Porto	Week 16, 2027 19 – 23 April 2027	1 Week	Onsite	€5,700
Cairo	Week 17, 2027 26 – 30 April 2027	1 Week	Onsite	€4,100
Lisbon	Week 17, 2027 26 – 30 April 2027	1 Week	Onsite	€5,700
Abu Dhabi	Week 18, 2027 3 – 7 May 2027	1 Week	Onsite	€4,700
Accra	Week 18, 2027 9 – 13 May 2027	1 Week	Onsite	€4,100
Berlin	Week 20, 2027 17 – 21 May 2027	1 Week	Onsite	€5,700
San Diego	Week 21, 2027 24 – 28 May 2027	1 Week	Onsite	€14,000
Muscat	Week 21, 2027 30 May – 3 June 2027	1 Week	Onsite	€5,700

Frequently asked questions

What does this course cover?

OverviewMedical device and IVD post-market surveillance is an advanced one-week course for quality, regulatory, vigilance and safety professionals who need a Post-Market Surveillance and Vigilance Control File. The course addresses fragmented evidence through PMS planning, complaint intake, signal and trend analysis, reportability decisions, serious-incid…

Are training dates available?

Yes. Available dates and destinations are listed in the course dates section on this page.

How can I register?

Choose an available date on this page and complete the registration form, or send a programme enquiry.

Can I download the course brochure?

Yes. Use the brochure download link provided on this page.

Medical Device and IVD Post-Market Surveillance Course