Rigorous quality control and performance testing of manufactured medical devices according to ISO 13485:2021 standards. Testing ensures safety, functionality, and compliance with regulatory requirements.
Manufactured by
Slovenia
MOOR Ortotika in Protetika specializes in manufacturing custom-made orthopedic devices and prosthetics designed to enhance patients' quality of life. The company provides individually tailored medical aids and assistive devices that meet specific clinical and personal requirements for optimal patient comfort and functionality.
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Abingdon Health plc · United Kingdom
Comprehensive quality control methodologies and testing services ensuring diagnostic product performance, safety, and regulatory compliance throughout manufacturing processes.
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Laboratory analysis service for medical device quality, safety, and microbiological validation. This service ensures compliance with ISO 13485 and regulatory requirements.
Mastor UK Ltd · United Kingdom
Quality verification and compliance testing service for medical devices and hospital equipment. Ensures equipment meets regulatory standards including CE, FDA and ISO certifications.
OPUS MEDICAL · Brazil
Comprehensive quality control and compliance service for medical imaging and diagnostic equipment. Includes calibration, maintenance, and technical validation to ensure equipment meets regulatory standards and operational performance requirements. Supports facility efficiency and reduces unplanned downtime through preventive and corrective service protocols.
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GUANGZHOU INSPECTION TESTING AND CERTIFICATION GROUP CO.,LTD. · China
Comprehensive testing and certification services for medical devices including biocompatibility, toxicological testing, and functional performance evaluation. GTTC provides one-stop solution for medical device quality assurance and regulatory compliance.
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Chemical analysis and testing service for medical device materials and components to ensure safety and compliance. Performed by accredited laboratory following international quality standards.
Point Share Medicine Technology (Shanghai) Co., Ltd. · China
Regulatory registration and testing service for active medical devices, passive medical devices, and in vitro diagnostic reagents. Supports compliance with medical device classification, clinical evaluation, and submission requirements for market authorization in regulated territories.
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Third-party testing service for microbiological analysis of medical devices, including sterility assurance and bioburden testing. Conducted according to ISO/IEC 17025 standards with CMA and CNAS certification.
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