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February 16, 2026
Approximately 5 minutes
Quality Management System and Risk Management for Medical Devices in Norway
Quality Management System and Risk Management for Medical Devices in Norway
1. Manufacturer Obligations
The manufacturer's work to ensure that the device complies with the regulations starts in the development phase, with the establishment of a quality management system and a system for risk management. The manufacturer shall reduce the risks for the user as far as possible without negatively affecting the benefit-risk ratio. If possible, this should be done through the use of safe design and manufacturing. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/quality-management-system-and-risk-management
2. Quality Management System – Relevant Standard
EN ISO 13485 «Medical Devices — Quality management systems — Requirements for regulatory purposes» includes among others:
- Management’s responsibility
- Resource management
- Development and design
- Purchasing
- Production
- Measurement, analysis, and improvements https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/quality-management-system-and-risk-management
3. Risk Management – Relevant Standard
EN ISO 14971 «Medical devices — Application of risk management to medical devices» includes among others:
- Description of the risk management process
- The plans for risk management, risk analysis and risk evaluation
- Risk reduction measures, evaluation of residual risk and benefit-risk ratio
- Review of the risk management activities
- Risk management during production and after the device has been made available on the market https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/quality-management-system-and-risk-management
4. Overview of Requirements
An overview of the requirements for the manufacturer's quality management system can be found in MDR Article 10 and IVDR Article 10. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/quality-management-system-and-risk-management
5. Harmonised Standards
These are just two of many harmonised standards and there are several that are relevant to medical device manufacturers. See separate website for more information on Harmonised Standards. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/quality-management-system-and-risk-management
6. EU Regulations
MDR - Regulation (EU) 2017/745 on medical devices IVDR - Regulation (EU) 2017/746 on in vitro diagnostic medical devices https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/quality-management-system-and-risk-management
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