RegPro Medical

Risk Management is the key to a safe and effective medical device and a smooth-running quality management system. Risk management is a continuous process throughout the lifecycle of the medical device to identify, analyze, control, and monitor risks to the patient, user, and environment. The Risk Management Plan and Risk Management Report are established at the very beginning of any effective medical device development project.  And your Risk Management File will serve as a roadmap throughout the device lifecycle to guide critical decisions about design, manufacturing, verification and validation, and post-market surveillance. The Risk Management Report is an essential element within the CE technical documentation, FDA device master record, medical device file, and regulatory applications in many jurisdictions.  Most importantly, the Risk Management File is a living document that is continuously updated and refined and re-reviewed in audits, inspections, and regulatory applications.