GET TO KNOW OUR CERTIFICATIONS.
FDA Registered
FDA registration (not "certification") is mandatory for facilities that produce, pack, or store food, drugs, medical devices, and cosmetics for the US market. While the FDA does not "certify" products or establishments, it issues export certificates for regulated goods.**
CE Certifications
CE marking is a mandatory conformity mark for products sold within the European Economic Area (EEA), signifying compliance with EU safety, health, and environmental protection regulations.**
ISO 9001:2015
ISO 9001:2015 is the internationally recognized standard for Quality Management Systems (QMS), focusing on risk-based thinking, leadership engagement, and continuous improvement to ensure consistent product/service quality.
ISO 13485 Certification
ISO 13485:2016 certification is the global standard for Medical Device Quality Management Systems (QMS), crucial for demonstrating safety, regulatory compliance (e.g., EU MDR, FDA QSR), and efficacy.
SIMAP Certification
The Surgical Instrument Manufacturers Association of Pakistan (SIMAP) membership/certification, which verifies, attests, and promotes high-quality, export-standard surgical instruments from Sialkot, Pakistan.
SCCI Certification
"SCCI Certification" typically refers to membership or documentation provided by the Sialkot Chamber of Commerce & Industry (SCCI) in Pakistan, a major trade body representing export-oriented industries.
