Quality management system and risk management
The manufacturer shall reduce the risks to 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.
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 may use the harmonised standards for quality management system and risk management to meet the relevant requirements of the regulations.
Quality management - 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
- Measurement, analysis, and improvements
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 equipment has been made available on the market
- 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.
An overview of the requirements for the manufacturer's quality management system can be found in MDR Article 10 and IVDR Article 10.