National Physicians Week, March 25 - 31, 2022

Our quality difference

From research to registration, AG Industries is committed to meeting all regulatory requirements with a quality system designed to meet and exceed our customers’ expectations.

Whether you are seeking to update components of your existing device or create cutting edge, innovative, full filtration systems, we have vertically integrated our manufacturing lines to ensure process and quality control every step of the way. AG will be your partner during concept development, manufacturing, testing, validation, and beyond.

Dedicated to the highest standards of operation through every step of a project, our facilities are FDA registered and are ISO 13485:2016 and MDSAP certified. Over 37 years of experience provides the deep well of resources needed to develop innovative designs and engineering solutions. Additionally, our expert team of engineers, project managers, and quality assurance professionals work with you to ensure a smooth process from the first sparks of creation to submission of your 510(k) applications. Aligning your direction and requirements with our techniques and commitment to excellence is the most efficient and effective path to bring your product to market.

Quality Capabilities

  • FDA Registered Facility
  • U.S. FDA 510k submissions
  • MDD Compliance and CE Marking
  • Quality Management System in place
  • US 21 CFR 820 Design Control Compliance
  • ISO Design Control
  • Certified to ISO 13485:2016
  • Utilization of ISO 14971 Risk Management Process
  • Health Canada Licensed Products
  • EU Authorized Representative – Emergo Group

    EMERGO EUROPE
    Prinsessegracht 20
    2514 AP The Hague
    The Netherlands

ISO Certifications

  • ISO 13485:2016

Certifications

  • MDSAP Facility
    • St. Louis, Missouri
    • Tijuana, Mexico

Download ISO & MDSAP Certifications

Download Health Canada Registration