ISO 14971 Risk Management for Medical Devices Training

The ISO 14971 Risk Management for Medical Devices Course offers a complete introduction to ISO 14971, the globally recognised standard for medical device risk management. It is ideal for professionals in quality, regulatory, R&D, or design roles who need to manage product risk efficiently and align with global compliance standards.

Key Topics Covered 

• Principles of ISO 14971: Understand the standard’s structure and approach to risk 

• Risk Analysis: Learn how to identify hazards, estimate risks, and determine use-related risks 

• Risk Control: Explore how to select, implement, and evaluate control measures 

• Lifecycle Risk Review: Manage residual risk and perform post-market surveillance 

• Integration with Quality Systems: Align risk with QMS and regulatory frameworks

Course Benefits

• Understand ISO 14971 Clearly: Gain practical knowledge to apply the risk management process across all stages of product development
• Improve Regulatory Readiness: Prepare your organisation for audits and reduce compliance risks
• Increase Product Safety: Build safer medical devices by identifying and managing potential hazards early
• Enhance Decision-Making: Support teams in evaluating benefit-risk profiles effectively
• Boost Career Growth: Add specialised ISO 14971 expertise to your professional profile

Attending this ISO 14971 Risk Management for Medical Devices Training Course can provide attendees with comprehensive insights into Risk Management processes, methodologies, and best practices within the medical device industry. Here are the individuals who might benefit from attending an ISO 14971 Risk Management for Medical Devices Training Course:

• Medical Device Manufacturers
• Quality Control Professionals
• Regulatory Affairs Professionals
• Risk Management Professionals
• Clinical Research Professionals
• Validation and Verification Engineers
• Biomedical Engineers
• Legal and Compliance Professionals

Module 1: Introduction to ISO 14971

• Introduction
• Scope
• Terms and Definitions

Module 2: General Requirements for Risk Management

• Risk Management Process
• Management Responsibilities
• Qualification of Personnel
• Risk Management Plan
• Risk Management File

Module 3: Risk Analysis

• Risk Analysis Process
• Intended Use and Reasonably Foreseeable Misuse
• Identification of Characteristics Related to the Safety
• Estimation of the Risk(s) for Each Hazardous Situation

Module 4: Risk Evaluation

• Overview of Risk Evaluation

Module 5: Risk Control

• Risk Reduction
• Risk Control Option Analysis
• Implementation of Risk Control Measure(s)
• Residual Risk Evaluation
• Risk/Benefit Analysis
• Risks Arising from Risk Control Measures
• Completeness of Risk Control

Module 6: Evaluation of Overall Residual Risk Acceptability

• Risk Acceptability

Module 7: Risk Management Review

• Risk Management
• Effective Management of Risk

Module 8: Production and Post-Production Activities

• General
• Information Collection
• Information Review
• Actions

By the end of the course, you will be able to:

• Explain the purpose and benefits of ISO 14971 in medical device development
• Perform risk analysis and evaluation for devices across their lifecycle
• Apply appropriate control strategies and evaluate residual risk
• Document risk management activities effectively
• Support regulatory compliance through post-production monitoring

To achieve the ISO 14971 Risk Management for Medical Devices Training, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice 

• Total Questions: 30 

• Total Marks: 30 Marks 

• Pass Mark: 50%, or 15/30 Marks 

• Duration: 40 Minutes