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.
|Indianapolis||ISO 13485 Quality System Certificate|
|U.S. Food and Drug Administration||1833117|
|Europe EC Certificates||EC Certificate CE 66745|
|EC Certificate CE 597141|
|Health Canada||Quality Sys. Cert. MD560630|