3.2. Production Support
Providing ongoing technical assistance, troubleshooting, and maintenance to ensure smooth and efficient manufacturing operations, while addressing any issues that arise to maintain consistent product quality and regulatory compliance.
Approval and release of each production batch for distribution based on meeting the specified quality and regulatory requirements.
Inspection and testing of raw materials, components, and supplies to verify conformance before use in manufacturing.
Monitoring and testing of the manufacturing process to identify and address any quality issues during production.
Final inspection and testing of the finished medical device to ensure it meets all quality and regulatory specifications before release.
Identification, investigation, and resolution of any product or process deviations from the established requirements.
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Maintaining the accuracy and reliability of the equipment and instruments used in the manufacturing and testing processes.