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Quality and Performance Assurance of Diagnostic Systems
PT. Sintech Manunggal Sejahtera ensures that every diagnostic instrument and reagent delivers reliable performance through technical validation, laboratory testing, and ongoing performance monitoring. This approach guarantees consistent, accurate results suitable for routine use in clinical laboratories.
All quality assurance activities are designed to support the reliability of diagnostic systems while ensuring compliance with applicable quality standards and medical device regulations.
Scope of Quality & Performance Assurance
Performance Verification
Performance verification is conducted to ensure that instruments and reagents operate according to defined technical specifications. Evaluations cover key performance parameters relevant to clinical use, ensuring the system is consistently ready for laboratory operations.
Calibration & Maintenance
Calibration and maintenance activities maintain system stability and accuracy over the long term. This approach helps minimize deviations in test results and supports continuous operational reliability of diagnostic instruments.
Compliance & Documentation
All quality assurance processes are supported by thorough technical documentation. Compliance with quality standards and medical device regulations is integral to every stage of system verification and maintenance.
Continuous Approach to Quality
Sintech’s Quality & Performance Assurance is carried out continuously to ensure that every product and diagnostic system consistently meets expected performance standards throughout its lifecycle.
Learn More About Quality Assurance
For more information on our quality approach, technical validation, and compliance documentation, please visit our Quality Assurance section.