Support in Risk Analysis Development
Risk management is one of the key pillars of medical device regulation and is mandatory under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). ISO 14971 sets out a structured approach to identifying, evaluating, controlling, and monitoring the risks associated with a medical device’s lifecycle.
We provide specialized technical support in developing and implementing risk management processes, ensuring compliance with ISO 14971 and its integration into the company’s Quality Management System.
Our services include
ISO 14971
Planning and structuring the risk management process according to ISO 14971
Design, Manufacture, Use, and Disposal
Identifying and evaluating hazards and potential risks associated with the design, manufacture, use, and disposal of the device
Risk Analysis and Management Reports
Developing risk analysis and management reports, including:
-Risk management plan;
-Risk analysis;
-Residual risk evaluation;
-Final risk management report;
Support in Integrating Risk Management
Support in integrating risk management with clinical data, production control, and post-market surveillance (PMS and PMCF)
Review and Update of Risk Documentation
Periodic review and update of risk documentation, based on new information, market feedback, or regulatory changes
