Risk Management Combines Compliance & Common Sense
- Aside from being a regulatory requirement, a systematic risk management program is an intelligent way to allocate precious operating resources.
- A good risk management system allows you to sensibly and statutorily answer questions like, “How much? For how long?”
- The benefits of using a medical device must outweigh the risks. A risk management process is needed because there is always some degree of risk associated with the use of a medical device.
- There is an inseparable link between compliance and common-sense.
The ComplianceAcuity Risk Management Solution
- Your ability to effectively manage operating resources will be improved using a proper risk management system.
- ComplianceAcuity adheres closely to ISO 14971 guidelines for the purpose of satisfying related requirements from the U.S. FDA and ISO 13485.
- Consistent with the principles of ISO 14971 and current industry best-practices, ComplianceAcuity can guide you to seamlessly integrate risk management throughout the quality management system and the entire device life-cycle. Our solution includes:
- How to prepare a Risk Management Plan
- Risk Management clearly mapped to all phases of the device life-cycle
- How to define risk acceptance criteria that reduce subjectivity and the questionable guessing typically associated with risk evaluation
- How to set up a Risk Management File
- Risk Analysis, Evaluation, and Control
- Residual Risk Evaluation
- Production and Post-Production Activities
- Risk Management Reporting
- Forms and templates to help you hit the ground running
“Thanks! This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it. For the SOPs you have sent me, I really like the breadth and depth of what you provided. It gives me an excellent platform to customize from.”
- Sr. Process & Quality Manager