Certificates

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Siora believes that high quality standards and principles are the essential foundations for ensuring above and beyond customer satisfaction.
Therefore, Siora implements its quality guidelines in all aspects of daily internal and external business, and the responsibility for maintaining this policy is entrusted onto each and every company employee.

The key to our professional strategic approach is continuously innovating and improving our processes, while aligning our quality policy with our customers’, patients’ and partners’ needs.
In our efforts to ensure constant delivery of high quality products and solutions, Siora facilities are regularly audited by internal and external authorities.

Siora’s certification range covers the design, development, manufacturing, marketing, logistics, sales, order processing and distribution of our products, solutions and services.
Siora’s commitment to quality is reflected in its demanding quality management system, which is compliant with laws and regulations in the Medical Device field, including, but not limited to:

  • CE Certificate for Interlocking Nails
  • ISO 9001 : 2015 Certificate
  • ISO 13485 : 2016 Certificate
  • CE Certificate for Locking Plates & Screws
  • Loan Licence for Sterilization MD 10 – (Indian FDA)
  • Non Conviction Certificate
  • Market Standing Certificate
  • Free Sale Implants Certificate – (Indian FDA)
  • Manufacturing Licence / for Instruments – MD 05
  • Medical Device Manufacturing Licence/Drug Licence – MD 09 – (Indian FDA)
  • Certificate of Recognition One Star Export House
  • Manufacturing Licence from Directorate of Industrial Safety & Health
  • Free Sale Instruments Certificate – (Indian FDA)

International Certifications

CE Certificate for Interlocking Nails

ISO 9001 : 2015 Certificate

ISO 13485 : 2016 Certificate

CE Certificate for Locking Plates & Screws

Certifications from Indian Government

Loan Licence for Sterilization MD 10 - (Indian FDA)

Non Conviction Certificate

Market Standing Certificate

Free Sale Certificate - (Indian FDA)

Manufacturing Licence / for Instruments - MD 05

Medical Device Manufacturing Licence/Drug Licence - MD 09 - (Indian FDA)

Certificate of Recognition One Star Export House

Manufacturing Licence from Directorate of Industrial Safety & Health

Free Sale Instruments Certificate - (Indian FDA)

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