Device Safety and Vigilance
This module delivers an introduction to the basics of device safety and vigilance, including regulatory requirements in the US, Europe, Australia, Canada and Japan, medical device reporting, trend analysis and risk management. This course explains the regulatory issues across global government agencies responsible for device safety.
This course will provide learners with the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international safety and reporting standards.
Course Content:
- History of Medical Device Reporting
- Device Vigilance Definitions
- Acronyms Used for Device Safety
- MDR Reportable Events
- Device Vigilance Process
- Assessing Device Adverse Events
- Serious Adverse Event for Devices
- Unanticipated ADE
- Expedited Reporting – USA
- MDR – Decision Tree
- US Reporting
- US Reporting – Clinical Trials
- Alternative Summary Reporting
- Expedited Reporting – Europe
- Expedited Reporting – Canada
- Expedited Reporting – Australia
- Japanese Reporting
- Trend Analysis
- Matrix of Safety Regulations
- Postmarketing Requirements for Devices
- Medical Devices: Definitions and Report Types
- Customer Complaint
- 820.198 Complaint Files – Procedure
- 820.198 Complaint Files – MDR
- An MDR Reportable Event
- What is Medical Device Reporting (MDR)?
- 803.17 Complaint Files – MDR
- MDR – Reporting Requirements
- MDR: 5-day Report
- Non-MDR Complaints
- Trend Analysis & Risk Management
- Medical device safety and risk management
- Risk Assessment
- Class of Device
- Risk Management
- Sample Trend Analysis (based on data from the FDA MAUDE database)
- Analysis by Device Problem
- Analysis by Event Type
- Analysis by Remedial Action
- Device Problem & Event Type