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Calibration requirements in ISO 13485
Updated: August 28, 2023 Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485, Clause...
Updated: August 28, 2023 Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485, Clause 7.6 (Control of monitoring and measuring equipment), mean high precision and close monitoring. Accuracy of...
Monitoring and measurement of processes in ISO 13485: How to comply with section 8.2
Updated: October 4, 2023. Monitoring and measurement focus on the quality of the product or services, which reflects the effectiveness...
Updated: October 4, 2023. Monitoring and measurement focus on the quality of the product or services, which reflects the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have...