APIS Logo
Materiovigilance
APIS Professional Program

Materiovigilance

Comprehensive medical device safety monitoring, adverse event reporting, risk management, complaint handling and post-market surveillance.

Course Overview

Materiovigilance (MvPI) is the science and activities related to the detection, collection, assessment, monitoring and prevention of adverse events or risks associated with the use of medical devices.

Course Modules

Module 1: Introduction to Materiovigilance

  • Definition of Materiovigilance
  • History of Materiovigilance
  • Importance of Medical Device Safety
  • Scope of Materiovigilance
  • Medical Device Lifecycle
  • Overview of Medical Device Industry
  • Materiovigilance Programme of India (MvPI)

Module 2: Medical Device Fundamentals

  • Definition of Medical Devices
  • Classification of Medical Devices
  • Active Medical Devices
  • Non-Active Medical Devices
  • Implantable Medical Devices
  • In-Vitro Diagnostic Devices (IVDs)
  • Software as a Medical Device (SaMD)
  • Device Risk Classification

Module 3: Regulatory Framework

  • CDSCO Medical Device Regulations
  • Medical Device Rules (MDR) 2017
  • Materiovigilance Programme of India (MvPI)
  • US FDA Medical Device Regulations
  • European Medical Device Regulation (EU MDR)
  • ISO 13485 Overview
  • ISO 14971 Risk Management Overview

Module 4: Adverse Event Reporting

  • Medical Device Adverse Event (MDAE)
  • Serious Adverse Event
  • Device Malfunction
  • Near Miss Events
  • Product Quality Issues
  • Reporting Criteria
  • Reporting Timelines
  • Reportable Events

Module 5: Materiovigilance Reporting System

  • Sources of Reports
  • Healthcare Professional Reports
  • Manufacturer Reports
  • Consumer Reports
  • User Facility Reports
  • Reporting Forms
  • Data Collection Process
  • Event Documentation

Module 6: Case Processing

  • Case Intake
  • Initial Assessment
  • Case Triage
  • Data Entry
  • Medical Review
  • Quality Review
  • Follow-Up Activities
  • Case Closure Process

Module 7: Device Event Investigation

  • Root Cause Analysis
  • Failure Investigation
  • Device Deficiency Assessment
  • Product Complaint Investigation
  • Corrective Actions
  • Preventive Actions (CAPA)
  • Trend Analysis

Module 8: Risk Management

  • Risk Identification
  • Hazard Analysis
  • Risk Assessment
  • Risk Evaluation
  • Risk Control Measures
  • Residual Risk Assessment
  • Benefit-Risk Analysis

Module 9: Signal Detection & Trend Analysis

  • Signal Detection Concepts
  • Event Trending
  • Signal Validation
  • Signal Assessment
  • Risk Evaluation
  • Signal Communication
  • Risk Mitigation Measures

Module 10: Post-Market Surveillance (PMS)

  • Introduction to PMS
  • Post-Market Clinical Follow-Up (PMCF)
  • Device Performance Monitoring
  • Safety Monitoring Activities
  • Vigilance Reporting
  • PMS Planning
  • PMS Reports

Module 11: Quality Management Systems

  • Quality Management System (QMS)
  • ISO 13485 Requirements
  • Documentation Control
  • Change Control
  • Deviation Management
  • CAPA Management
  • Internal Audits

Module 12: Complaint Handling

  • Product Complaint Management
  • Complaint Evaluation
  • Complaint Investigation
  • Complaint Documentation
  • Escalation Procedures
  • Regulatory Reporting Requirements

Module 13: Medical Device Standards

  • ISO 13485
  • ISO 14971
  • IEC Standards Overview
  • Good Documentation Practices (GDP)
  • Compliance Requirements
  • Inspection Readiness

Module 14: Materiovigilance Databases & Systems

  • Device Safety Databases
  • Complaint Management Systems
  • Electronic Reporting Systems
  • Data Management Basics
  • Reporting Tools Overview

Module 15: Audits & Inspections

  • Regulatory Inspections
  • Internal Audits
  • Supplier Audits
  • Audit Preparation
  • Inspection Management
  • CAPA Follow-Up

Module 16: Career Opportunities in Materiovigilance

  • Materiovigilance Associate
  • Medical Device Safety Associate
  • Complaint Handling Specialist
  • Post-Market Surveillance Associate
  • Quality & Compliance Associate
  • Risk Management Associate
  • Regulatory Affairs Associate
  • Career Growth Pathways

Practical Training

✅ Medical Device Adverse Event Case Studies
✅ Event Reporting Exercises
✅ Root Cause Analysis Workshops
✅ Complaint Handling Scenarios
✅ Risk Assessment Exercises
✅ CAPA Documentation Practice
✅ Signal Detection Demonstrations
✅ Post-Market Surveillance Activities

Interview Preparation

🎯 Materiovigilance Interview Questions
🎯 HR Interview Preparation
🎯 Resume Building Guidance
🎯 LinkedIn Profile Optimization
🎯 Professional Communication Skills
🎯 Email Writing Basics
🎯 Corporate Etiquette

What You'll Achieve

Gain comprehensive understanding of medical device safety monitoring, adverse event reporting, complaint handling, risk management, post-market surveillance, quality systems and regulatory compliance.