Most medical device companies are audited by regulatory bodies at least once per year depending upon their geography. Incorporating a solid Risk Management Process can not only mitigate regulatory risk but also deliver peace of mind to all stakeholders in the enterprise as you launch new products. Whether you are still using a legacy, paper-based quality management system (QMS) or an electronic Quality Management System (eQMS), risk management is critical.
Learn best practices in the Risk Management Process for medical devices with our new eBook, Risk Management Process: Medical Device Best Practices & Requirements to Control Risks to Users, Patients and the Environment.
In it, you’ll learn:
- Why the Risk Management Process should be applied throughout the lifetime of the device
- How working as a team enables the identification of risks and the implementation of effective risk control measures
- How the deliverables for the risk management process are interwoven within the Design and Development Process, as risk management is considered throughout the development of a device and whenever changes are made to a device
- Why it’s critical for medical device companies to create a risk management plan for review and also take a condensed approach in which everything is done at once and built into the design and development process
