Risk management has become central in the life cycle of each medical device, and being one of the most important tools in the CE-marking process since it enables the manufacturer to identify the product safety requirements. It involves identifying, assessing, controlling, and monitoring risks associated with the development, manufacturing, and use of medical devices.
Risk management according to the ISO 14971:2019 standard involves risk identification, estimation, evaluation, control, and monitoring, to ensure the safety and effectiveness of the medical device.
Our team offers comprehensive risk management support tailored to the needs of your company and products, whether it’s developing overarching strategies or addressing specific areas.
We understand the risk management requirements and techniques that relates to other standards that reference ISO 14971 such as;
- ISO 14155 Clinical Investigation
- IEC 62366 Usability Engineering
- ISO 62304; IEC/TR 80002 Software
- ISO 10993 Biological Evaluation.
- IEC 60601 Medical Electrical Equipment
Example of services that we can provide;
- Efficiently manage risk management activities.
- Seamlessly integrating risk management into the quality management system.
- Conducting audits of risk management processes, plans, and reports.
- Employing diverse methods to support risk analysis.
- Providing customized or open-class training sessions.
Contact us for further information
Our risk management experts stand ready to assist your organization in attaining compliance while boosting productivity within your risk management operation. Contact us here if you have any questions or want to learn more about how we can support.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
