Risk management according to MDR & ISO 14971 (Basic)

The 2 main goals of MDR are to ensure that medical devices on the EU market deliver the claimed clinical benefit and are safe to use. With that in mind, risk management has become the backbone of manufacturers' operations, covering every aspect of medical device technical documentation. State of the art in risk management is ISO 14971. Manufacturers who implement ISO 14971 are on the right track toward MDR compliance and more importantly to put devices on the market with risks mitigated as much as possible.

There are multiple risk analysis techniques and multiple approaches to risk management. MDR sets the framework, and ISO 14971 provides tools for professionals to build a robust, effective and compliant risk management file. Other major standards also interact with ISO 14971; it is crucial to learn how to create an effective risk management system using other relevant standards to your benefit. 

Key Topics Covered:

• Requirements of MDR on risk management 
• Requirements of ISO 14971 & MDR/ ISO differences 
• What is the process of risk management 
• Role of other international standards in the risk management 
• Most common issues & Best Practices

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

• Understand the requirements of MDR & ISO 14971 on risk management 
• Understand the risk management process 
• How to integrate other international standards into risk management 
• Avoid the most common issues 

Target Audience: Regulatory Affairs, Quality Management, Packaging Engineers, Product Development, Sustainability Chain and Compliance Managers 

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH