ISO 13485:2016

Quality & Certifications

Committed to the highest international standards

Excellence in Every Process

At Comercial A&B S.A., quality is the fundamental pillar of our operation. We apply rigorous procedures to ensure quality processes throughout the supply chain.

Our Quality Management System is designed to meet and exceed regulatory requirements, ensuring that every product meets the highest safety and efficacy standards.

ISO 13485:2016 Certified System

Pillars of Our Quality

Documentation

Complete documentation systems ensuring traceability and control.

Verification

Rigorous controls at every stage of the production process.

Traceability

Complete tracking from origin to end user.

Safety

Strict protocols to ensure patient safety.

ISO 13485:2016 Certificate - Comercial A&B S.A.
Verified Certificate

Certificate Details

Our ISO 13485:2016 certification endorses our commitment to quality in the manufacturing and marketing of medical devices.

Standard ISO 13485:2016
Scope Medical Devices Management System
Registration No. PT-2023/SGMD 0073
Issue Date December 27, 2023
Expiry Date December 26, 2026
Certification Body IQNet / APCER

Certified Products

Our certification covers the manufacturing and marketing of the following medical products:

Gel Cards

Manufacturing and marketing of gel cards applied to immunohematology.

Sterile Meshes

Manufacturing of sterile meshes for hernia and prolapse repair.

Suburethral Slings

Production of sterile suburethral slings for urinary incontinence.

Trust in Our Quality

Discover how our certified products can help your institution.