Since 1992, Sharma Orthopedic Limited has maintained stringent quality control systems to support surgeons, hospitals, and healthcare procurement partners across 50+ countries. Our state-of-the-art manufacturing infrastructure operates under globally accredited Quality Management Systems (QMS), ensuring every orthopedic implant and surgical instrument fulfills rigorous clinical, biomechanical, and regulatory requirements.
MD-5 & MD-9 Medical Device Licenses
Quality Management System
Medical Devices QMS Standard
European Conformity Standard
USA, Brazil, Australia, Canada Compliant
Regulatory Filings in Progress
Zero Defect Manufacturing Recognition
Our regulatory management team maintains end-to-end technical documentation (Device Master Files, STED dossier formatting, Risk Assessment under ISO 14971, and Clinical Evaluation Reports) to provide seamless registration support for international distributors and hospital tenders.
Certified design, development, and cleanroom manufacturing processes verified through rigorous annual third-party audits to guarantee product traceability and structural consistency.
Compliance with European Union Medical Device Directive (MDD) / Medical Device Regulation (MDR), ensuring unrestricted clinical deployment across European and aligned global healthcare systems.
Fully authorized by India's Central Drugs Standard Control Organisation (CDSCO) for manufacturing Class A, B, C, and D high-risk orthopedic implants under strict state and national oversight.
Every orthopedic plate, intramedullary nail, spinal rod, and joint prosthesis crafted at our 62,391 sq. ft. facility is subjected to rigorous metallurgical verification and non-destructive testing (NDT).
Sharma Orthopedic active market approvals, health ministry registrations, and commercial distribution presence across Latin America, Asia-Pacific, the Middle East, Africa, and Europe:
Partner with an accredited manufacturer. Our RA team provides complete technical files, Free Sale Certificates (FSC), and registration support for hospital tenders.