Risk Management

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