ISO 13485 & CE Certifications | Siora Surgicals Quality Assurance

Rigorous Quality Control & International Compliance

With over 35 years of specialized experience in orthopedic manufacturing, Siora Surgicals Private Limited operates under strict Quality Management Systems (QMS). Our manufacturing facility in Sonipat, Haryana, utilizes advanced CNC/VMC technology and ISO Class 10,000 cleanroom packaging. Every product line—from interlocking nails to locking plate systems—undergoes 100% inspection to ensure material traceability, biocompatibility, and optimal surgical performance for healthcare institutions worldwide.

Global Standards

International Certifications

Siora Surgicals holds accredited CE marks and ISO standard certifications, providing international hospital procurement authorities and medical distributors complete assurance of quality and product safety.

CE Certificate for Interlocking Nails

ISO 9001:2015 Quality Management Certificate — Siora Surgicals

ISO 9001 : 2015 Certificate

ISO 13485:2016 Medical Devices Quality Certificate — Siora Surgicals

ISO 13485 : 2016 Certificate

CE Certificate for Locking Plates and Screws — Siora Surgicals

CE Certificate for Locking Plates & Screws

Regulatory Approvals

Certifications from Indian Government & FDA

Our manufacturing unit, sterilization processes, and export licenses are fully authorized and regularly audited by official statutory bodies and regulatory authorities.

Manufacturing Licence from Directorate of Industrial Safety & Health

Medical Device Manufacturing Licence - MD 09 (Indian FDA)

Medical Device Manufacturing Licence - MD 05 (Indian FDA)

Loan Licence for Sterilization MD 10 (Indian FDA)

Free Sale Certificate Implants (Indian FDA) - Part 1

Free Sale Certificate Implants (Indian FDA) - Part 2

Free Sale Certificate Instruments (Indian FDA)

Certificate of Recognition - One Star Export House

Partner with a Certified Global Orthopedic Manufacturer

Looking for reliable OEM/Contract Manufacturing or seeking to become a regional distributor? Our quality compliance team is ready to provide complete technical dossiers, product documentation, and certified implant samples.

ISO & CE Certifications