Quality & Regulatory Downloads

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

Indianapolis
ISO 13485 Quality System Certificate (PDF)

Maple Grove
ISO 13485 Quality System Certificate (PDF)

Maple Plain
ISO 13485 Quality System Certificate (PDF)


US FDA Quality Systems Regulations (QSR)

U.S. Food and Drug Administration

CRI Indianapolis Registration Number: 1833117
CRI Maple Grove Registration Number: 3010133999


International Certifications

Europe EC Certificate 


EC Certificate CE 66745

EC Certificate CE597141

 

HEALTH CANADA
Canada Establishment License (PDF)


Global Regulatory Representatives

EC REPRESENTATIVE EUROPE
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel: (31) (0) 70 345-8570
Fax: (31) (0) 70 346-7299


Notified Body / Registrar / Certification Body

BSI maintains our ISO 13485:2003EC Certificate CE66745 and EC Certificate CE597141