- - the promotion and awareness of regulatory requirements as a management responsibility.An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
- - controls in the work environment to ensure product safety
- - focus on risk management activities and design transfer activities during product development
- - specific requirements for inspection and traceability for implantable devices
- - specific requirements for documentation and validation of processes for sterile medical devices
- - specific requirements for verification of the effectiveness of corrective and preventive actions
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