Glossary Term
Calibration Protocols
Definition
Calibration Protocols are standardized procedures used to verify and adjust the accuracy, precision, and functionality of instruments and equipment. In the MedTech industry, calibration protocols ensure that devices and manufacturing tools perform reliably within defined specifications, maintaining compliance with regulatory and quality standards.
Relevance to the MedTech Industry
Calibration Protocols are essential for ensuring the reliability and accuracy of medical devices and equipment used in patient care, diagnostics, and manufacturing. They minimize measurement errors, maintain device performance, and ensure compliance with standards such as ISO 13485 and FDA Quality System Regulations (21 CFR Part 820).
Additional Information & Related Terms
ISO 13485 Governs quality management for medical device manufacturers, including calibration processes.
Measurement Systems Analysis (MSA) Evaluates the accuracy and reliability of measurement systems.
Validation Protocols Complements calibration by ensuring that equipment consistently produces intended results.
Preventive Maintenance Often incorporates calibration as a key activity to ensure equipment reliability.