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

AG Industries products

Nonny - Full Face Pediatric CPAP Mask