There are 2 main risk approaches to focus on for the medical device quality management system.
1) “Product Risk Management” to be carried out in accordance with EN ISO 14971:2012 standard to fulfill the safety and performance requirements of medical device
2) Risk Management of Quality Management System
You can get support from the expert team of AdviQual in performing Risk Analysis for both processes.
Product Risk management ensures that products and production processes are safe and effective.
Risk management is a continous process that should be alive throughout life cycle of medical device. Therefore, it covers all life cyles of the product such as design, usage, production and monitoring post-production risks.
So you should keep the risk management file of the medical devices up-to-date throught the life of the product.
EN ISO 14971:2012 puts in order risk management steps as risk identification, risk assessment, risk reduction as far as possible.
Risk consists of two component parts.
- Probability and
The next step following the risk assessment stage is to control this generated risk. Risk control focuses on eliminating the hazards. If it can not be eliminated, the focus is on preventing or detecting events that lead to a hazardous situation. Checking the validity and effectiveness of each risk control can be achieved through validation studies which require engineering knowledge.
The possibility of damage should be re-evaluated after the risk control measurements are applied. It is required to check the effectiveness of the applied risk control and to verify that the risk control is being implemented in order to assess these remaining risks.
Risk analysis report shows that the risk management plan is applied with the information collected by using the appropriate methods from design, usage, production, and post-production, the acceptability of the residual risks and the risk-benefit analysis is performed.
RISK-BASED APPROACH TO MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM
EN ISO 13485: 2016 standard focuses on the concept of "Risk" much more than previous revisions. Risk management should not only be applied to all parts of the quality management system but also apply to the product.
The purpose of the risk-based approach to the quality management system is to support the safety and performance results of the product with quality management system implementations while complying with the regulatory requirements.
The most important benefits of the risk-based quality management system are the continuous improvement of the quality management system, such as the effective resource management, eliminating the risks in the quality system without negatively impacting the safety and performance of medical device, and the realization of critical preventive actions by establishing the criticality levels in solving the problems.
According to EN ISO 13485: 2016, quality management system headlines that are not limited to, but should be considered risk-based are:
6.2 Human Resources: The methods which are used in order to control competence and training effectiveness should be measured according to the risk-based ratio of performing work.
7.1 Product Realization: Processes should be assessed on a risk basis and their impact should be measured on product safety.
7.3 Design and Development: The risks of deviations in design inputs and outputs should be measured.
7.4 Purchasing: The choice of supplier and failure to meet the purchase requirements must be proportional with the device or the risk associated with the product purchased.
7.5 Production Validation: The approach to software validation is proportional to the risks of product use.
7.6 Measurement and monitoring: The feedback system should collect data from both production and post-production activities. The information should serve as a potential input to risk management to monitor and maintain product requirements and product realization improvement processes.
8.2 Feedback: The feedback system should collect data from both production and post-production activities. The information should serve as a potential input to risk management to monitor and maintain product requirements and product realization improvement processes.