Quality Certifications
Primary Certifications
Our core certifications that demonstrate our commitment to medical device quality and safety
ISO 13485
ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. This certification demonstrates our commitment to consistently providing medical devices and related services that meet customer and regulatory requirements.
Valid until: December 2026
Cert. No: ISO13485-2024-001
CE Marking
CE marking indicates that our products meet EU safety, health and environmental protection requirements. This allows us to freely market our medical devices across the European Economic Area, ensuring compliance with the Medical Device Regulation (MDR).
Valid until: March 2027
Cert. No: CE-MDR-2024-002
FDA Approved
FDA approval confirms that our medical devices meet rigorous safety and effectiveness standards for the US market. This certification validates our manufacturing processes, quality controls, and product performance through comprehensive regulatory review.
Valid until: December 2026
Cert. No: ISO13485-2024-001
WHO GMP
WHO GMP certification ensures our manufacturing processes follow internationally recognized standards for pharmaceutical and medical device production. This guarantees consistent quality, safety, and efficacy across all our products and production facilities.
Valid until: September 2027
Cert. No: WHO-GMP-2024-004
DUNS Registered Certificate
Our DUNS Registered Certificate verifies our business identity through the global Dun & Bradstreet system. It enhances credibility, ensures transparency, and builds trust with international partners, enabling smoother business transactions and recognition across global markets.
Valid until: August, 2026
D-U-N-S No: 771622969
Our Import Export Code (IEC) Certificate authorizes us to conduct international trade in goods and services. Issued by the Directorate General of Foreign Trade, it ensures legal compliance, facilitates global transactions, and strengthens our credibility with overseas clients and partners.
Valid from: JULY 2025
Cert. No: AAYFD2458D
ISO 13485:2016
Our ISO 13485:2016 certification demonstrates our commitment to quality management in medical device manufacturing. It ensures consistent product quality, regulatory compliance, and patient safety, reinforcing our reliability and trustworthiness in delivering healthcare solutions to global markets.
Valid until: May 2029
Cert. No: 220526501
Registration-cum Membership Certificate FIEO
Our Registration-cum-Membership Certificate (RCMC) validates our registration with recognized export promotion authorities. It authorizes us to export specific products, ensures compliance with trade regulations, and strengthens our credibility while enabling access to international markets and government export benefits.
Valid until: March 2028
Cert. No: RCMC/FIEO/13369/2025-2026
REGISTRATION - CUM - MEMBERSHIP CERTIFICATE PHARMEXCIL
Our Registration-cum-Membership Certificate (RCMC) validates our registration with recognized export promotion authorities. It authorizes us to export specific products, ensures compliance with trade regulations, and strengthens our credibility while enabling access to international markets and government export benefits.
Valid until: March 2027
Cert. No: RCMC/PHARMEXCIL/01818/2025-2026
Additional Regulatory Approvals
Supporting certifications that enhance our global compliance and market access
ISO 9001:2015
Quality Management System certification
Process optimization and continuous improvement
Customer satisfaction focus
Regular third-party audits
MDSAP
Medical Device Single Audit Program
Recognition in USA, Canada, Brazil, Japan, Australia
Streamlined regulatory compliance
Enhanced global market access
Our Quality Commitment
Beyond certifications, our dedication to excellence drives everything we do
Rigorous Testing
Every product undergoes comprehensive testing protocols before market release
Medical Validation
Clinical trials and medical board approvals for all healthcare solutions
Documentation
Complete traceability and documentation for regulatory compliance
Continuous Monitoring
Ongoing quality assurance and post-market surveillance programs
Manufacturing Excellence
Our commitment to quality is reflected in every aspect of our manufacturing process
Quality Tested
Manufacturing
Quality Control
Commitment
Questions About Our Certifications?
Our regulatory compliance team is here to help you understand our certifications and how they apply to your specific requirements.