Krishna Orthopedic Equipments is a specialized manufacturer of surgical implants and instruments, dedicated to precision engineering, rigorous quality control, and strict regulatory compliance.
Utilizing multi-axis Swiss-type CNC lathes and milling centers to achieve micro-tolerances required for complex joint and spinal implants.
Exclusive use of certified medical-grade raw materials, including Titanium Alloy (Ti-6Al-4V ELI), 316LVM Stainless Steel, and implantable PEEK, with full mill test report traceability.
Final cleaning, inspection, and packaging are conducted in ISO Class 7 clean rooms to ensure bioburden control prior to sterilization.
A timeline of our growth in the medical device manufacturing sector.
Krishna Orthopedic Equipments was founded with a primary focus on manufacturing basic fracture fixation systems using conventional machining.
Achieved comprehensive certification for Medical Device Quality Management Systems, standardizing our production environment.
Major infrastructure upgrade integrating 5-axis CNC machining centers for complex joint and spinal implant manufacturing.
Successfully obtained CE Marking and FDA 510(k) clearances, validating our products for international healthcare markets.
Our facility and products are audited and certified by leading global regulatory bodies, ensuring the highest standards of patient safety.
Ensures consistent production meeting customer and regulatory requirements.
Certifies our comprehensive quality management system for the design and manufacture of medical devices.
Compliance with stringent US federal regulations for medical devices.
Validates that our devices are safe and effective for the US healthcare market.
Allows free movement of our medical devices within the European market.
Indicates conformity with health, safety, and environmental protection standards for products sold within the EEA.
Compliance with the Medical Devices Rules, 2017.
Approved by the Central Drugs Standard Control Organization for domestic manufacturing and distribution.
Our workforce comprises specialized professionals dedicated to the stringent requirements of medical device manufacturing. Continuous training ensures adherence to evolving global standards.
Experts in CAD/CAM programming, optimizing toolpaths for complex anatomical geometries and maintaining micro-tolerances.
Specialists managing CMM inspections, surface finish analysis, and maintaining comprehensive Device History Records (DHR).
Dedicated team managing FDA submissions, CE technical files, and ensuring continuous QMS compliance.
Collaborating with orthopedic surgeons to develop next-generation implant designs and improved surgical instrumentation.
