Quality & Regulatory Downloads and International Regulatory Compliance Information

We are US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, and ISO 13485 certified Manufacturers.

We assist our customers with all of their regulatory requirements.

Quality Management System

ISO 13485 Quality System Certificate


US FDA Quality Systems Regulations (QSR)

U.S. Food and Drug Administration


Quality Management System

Health Canada

Quality Sys. Cert. MD560630