Global Compliance

Since 1992, Sharma Orthopedic has been at orthopedic implants, earning prestigious awards MSME Award for excellence in innovation and manufacturing.

CERTIFICATIONS & COMPLIANCE

We uphold the highest global standards with certifications

  • ISO 13485:2016 - Medical Device Quality Management
  • ISO 9001:2015 - Robust Quality Management
  • ISO 9001:2015 - Robust Quality Management
  • CDSCO (Indian FDA) - Licensed for MD-5 & MD
  • MDSAP Certification - Compliance in Australia
  • CE Certification - EU standard compliance
  • USFDA 510(k) Approval - Progressing for key orthopedic systems

With sales in 30+ countries across Latin America, offering such a comprehensive certified implant innovation and quality!

           

FORM MD-9
ISO 13485 - 2016 ORTHOPEDIC IMPLANT
ISO 13485-2016 SURGICAL MEDICAL DEVICES
ISO 9001 - 2015
CE CERTIFICATE
CE CERTIFICATE SURGICAL DISPOSABLE & RE-USABLE MD
CE CERTIFICATE N COV-2019 RAPID TEST CARD
WHO - GMP CERTIFICATE

Argentina
Colombia
ecuador
egypt
ethiopia
ghana
guatemala
herzegovina
honduras
indonesia
kenya
kosovo
macedonia
mexico
moldova
morocco
myanmar
nigeria
oman
panama
peru
philippines
serbia
sri lanka
syria
tanzania
thailand
ukraine
uruguay
zanzibar
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