Patient safety is our absolute priority. Our manufacturing processes are governed by a strict Quality Management System (QMS) that complies with global medical device regulations.
Official validations of our manufacturing standards.
Our core Quality Management System certification, ensuring that every process from design to delivery meets stringent international medical device standards.
Standardizes regulatory compliance for medical device manufacturing.
Demonstrates that our orthopedic implants are substantially equivalent to legally marketed devices, ensuring safety and efficacy for patients.
Regulatory clearance for US market distribution.
Validates that our products meet the essential health and safety requirements set out in European Directives.
Compliance with EU Medical Device Regulation (MDR).
Official registration with the Central Drugs Standard Control Organization, authorizing domestic manufacturing and sales.
National regulatory approval for medical devices.
Our in-house testing laboratory is equipped with advanced metrology and metallurgical analysis tools to verify that every batch meets exact specifications before release.
Optical Emission Spectroscopy (OES) is used to verify the chemical composition of all incoming raw materials against ASTM and ISO standards.
Coordinate Measuring Machines (CMM) and optical profile projectors ensure complex geometries match CAD models within micron tolerances.
Validation of cleaning processes and management of Gamma/ETO sterilization cycles to guarantee a Sterility Assurance Level (SAL) of 10^-6.
Comprehensive Device History Records (DHR) link every finished implant to its original raw material heat number and operator logs.
