Conigx is committed to upholding the highest standards of safety, quality, and regulatory compliance. Our certifications reflect our dedication to manufacturing precision surgical instruments for global healthcare markets.
Each certificate below documents our compliance with international medical device regulations and quality management systems.
Verified
1.
Medical Devices Quality Management System
Manufacturer and Exporter of Surgical, Dental, ENT, Ophthalmic and Plastic Surgery Instruments.
Certified in accordance with ISO 13485:2016 u2014 the international standard for quality management systems specific to medical devices.
Verified
2.
Quality System Regulation Compliance
Manufacture of surgical instruments u2014 added to the Green List of Import Alert #76-01 (exempt from detention without physical examination).
Compliance with the FDA Quality System Regulation of 1997, including current good manufacturing practice (cGMP) requirements under Title 21, Code of Federal Regulations (CFR), Part 820.
For copies of certificates, regulatory documentation, or distributor compliance packs, contact our export team.
