MY | ISO 14971:2019 Risk Management in Medical Devices

This course is designed for individuals in the medical device industry who are involved in Regulatory, Quality, Design (including design changes), Development, Manufacturing, Marketing Managers and personnel decision makers on management system strategy and Internal Auditors

The training provides:

• Identify the links between ISO 13485 (QMS) and ISO 14971 Risk Management
• Understanding how risk management relates to the product lifecycle
• understand how ISO 14971 applies to ISO 13485.
• Define risk management terminology
• Outline the stages of the risk management process
• Define the key deliverables of the risk management process
• Understand the latest updates of ISO 14971:2019

Content

Day 1:

Module 1: Overview of Risk Management

• Definition of Risk
• Links from ISO 14971 to ISO 13485, and Regulations
• General Requirement for Risk Management
• Phases of Risk Management

Module 2: Risk Management Process

• Risk Analysis
• Risk Evaluation
• Risk Benefit Analysis
• Risk Control
• Evaluation of Overall Risk
• Risk Management Review
• Production and Post-Production Information

Module 3: Risk Management Tools

• Understanding how and when in the lifecycle to use them
• PFMEA, Fault Tree Analysis

Module 4: Creating Risk Management File

• Minimal documentation

Day 2:

Module 5: ISO 14971:2019

• Introduction
• Terms & definitions
• ISO 14971:2019 Overview of structure and contents
• Current status