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Certifications & Quality Compliance

Certifications & Quality Compliance

At Delta Med Surgical, quality is our clinical responsibility. We operate a state-of-the-art manufacturing facility in Sialkot, Pakistan, that adheres to the most stringent international medical standards. Our certifications are a testament to our commitment to safety, precision, and excellence.

  1. ISO 13485:2016 Certified

We maintain a comprehensive Quality Management System (QMS) specifically for medical devices. This certification ensures that every stage of our production—from raw material sourcing to final finishing—is documented, audited, and optimized for surgical safety.

  1. FDA Registered (U.S. Food & Drug Administration)

Delta Med Surgical is an FDA-registered manufacturer, allowing us to supply the United States healthcare market. We comply with the Quality System Regulation (QSR) and ensure our instruments meet the rigorous safety and performance standards required for the American medical industry.

3. CE Marking (European Conformity)

Our instruments comply with the essential requirements of the Medical Device Regulation (MDR). The CE mark on our products indicates that they meet the health, safety, and environmental protection standards for the European Economic Area (EEA).

  1. SCCI & SIMAP Membership

We are proud active members of:

  • Sialkot Chamber of Commerce & Industry (SCCI)
  • Surgical Instruments Manufacturers Association of Pakistan (SIMAP)
  1. Material Excellence (ASTM & AISI)

We certify that our instruments are manufactured using premium medical-grade stainless steel, strictly following:

  • ASTM F899: Standard Specification for Wrought Stainless Steels for Surgical Instruments.
  • AISI 420/304: Ensuring high-carbon strength for cutting edges and superior corrosion resistance.

6. Free Sale Certificate (FSC)

We hold a Certificate of Free Sale, issued by the relevant regulatory authorities in Pakistan. This document confirms that our surgical instruments are legally manufactured and can be freely sold and exported to international markets.