Enhancing Your Risk Management Process
Medical device companies are required to implement risk management processes in compliance with ISO 14971.
All international regulatory agencies accept ISO 14971 as the Risk Management Standard for medical devices.
Complying with the ISO 14971 standard begins with an overall risk management framework that includes the Risk Management Plan, identifying risks, evaluating risks, establishing risk controls and generating the Risk Management Report. These elements comprise the Risk Management File.
Integrating Risk Management activities throughout the product life cycle is vital to ensuring the safety and effectiveness of products. Garrett Technologies, Inc. can assist with Risk Management File development or implementation of risk management processes required for compliance with ISO 14971.
