CERTIFICATIONS & COMPLIANCE

ISO 13485 CERTIFICATE

Our commitment to quality and patient safety is validated by international certifications and rigorous regulatory compliance.

0+
Countries Served
0+
Years of Excellence
ISO
ISO 13485
Certified
FDA
CE
Registered Facility
MDR
Compliant
ISO 13485:2016 Certification

ISO 13485:2016 Certification

Medical Device Quality Management System

View Certificate
CE Marking (EU MDR)

CE Marking (EU MDR)

European Conformity Assessment

View Certificate
FDA Registration (USA)

FDA Registration (USA)

U.S. Food & Drug Administration

View Certificate
Free Sale Certificate

Free Sale Certificate

Asia & Global Market Authorization

View Certificate
WHO GMP Certificate

WHO GMP Certificate

World Health Organization GMP

View Certificate
Importer Exporter Certificate

Importer Exporter Certificate

Government of India Export Authorization

View Certificate

Our certifications reflect our unwavering dedication to quality, safety, and trust.

Rigorous Quality Standards
Regular Audits & Compliance
Patient Safety First
Continuous Improvement
FAQ

Frequently Asked Questions

Biomedortho offers a wide range of orthopedic implant systems including trauma plates, locking plates, IM nails, spine systems, joint solutions, and related surgical instrumentation.

Yes. Our implants are manufactured under quality-controlled processes and are designed to meet applicable safety and biocompatibility requirements for surgical use.

Our team can help you choose the most suitable system based on the procedure type, anatomy, and surgeon preference. Contact us with your requirement and we will guide you.

Several of our implant systems and instruments are suitable for minimally invasive techniques. Please check the product-specific guidance for procedure compatibility.

Our locking plate systems are engineered for anatomical fit, stable fixation, and reliable performance across a broad range of trauma applications.

The pelvic portfolio includes contour-friendly designs and multiple plate configurations to help surgeons address the complexities of pelvic anatomy.

Post-operative care depends on the procedure and clinical protocol. Please follow the surgeon's guidance and the instructions provided with the implant system.

You can reach out through the contact form, email, or phone on this page. Our sales team will connect you with the appropriate product and regional representative.

Yes. We can share product catalogs, technical brochures, and other reference material based on the implant system or category you are interested in.

For selected products and regions, demonstration or sample requests may be arranged through our sales team after reviewing your requirement.

Take the Next Step With Us