Our Relationship - Quality System

Confidence Built In

At Ultimate, quality goes beyond the physical product. We strive to build quality into everything we do from interaction with our customers and vendors, to developing new materials and products, to providing marketing support for customer promotions. We have a strong sense of 'team' and work together, within a tight Quality Management System, to best serve our customers.

Ultimate Wireforms, Inc.

Quality Policy

Within the guidance of regulatory and statutory requirements, Ultimate's Quality Management System is committed to ensuring that we meet or exceed our customer requirements while maintaining a suitable, adequate and effective quality system. The involvement of all employees in this effort provides for a unified direction of process improvement and product development, with the aim of enhanced customer satisfaction.

We are committed to creating the high quality products and services you want and need. Our Regulatory Department can provide you with information regarding our Quality Management System or the safety of our products, or you may follow the links below for further information.

Domestic and International Regulatory Regulations, Compliance, and Certificates

Quality System for Medical Devices Certification
EN ISO 13485:2003 + AC:2007

US FDA Establishment Registration and Device Listing
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Europe - EC Directive 93/42/EEC Annex II, Article 3 Quality Assurance System Compliance
EC Directive 93/42/EEC Compliance Certificate

Europe - Declaration of Conformity to European Council Directive 93/42/EEC
Declaration of Conformity

Japan - Foreign Manufacturer Certification for Medical Devices
Japan Foreign Manufacturer Certificate

Notified Body/Registrar/Certification Bodies

Regulatory Affairs Incident Reporting
Emergo Europe(Authorized Representative)
Molenstraat 15
2513 BH The Hague
The Netherlands
http://www.emergogroup.com/contact

Notified Body
TÜV Rheinland
Product Safety GmbH
Am Grauen Stein
D-51105 Köln, Germany
http://www.tuv.com/us/en/index.html

ISO 13485:2003 certification and MDD compliance is audited by
TÜV Rheinland
Product Safety GmbH
Am Grauen Stein
D-51105 Köln, Germany
http://www.tuv.com/us/en/index.html

Should you have a concern with any of our products, contact Ultimate for an immediate response:

Phone: 860.582.9111
Toll free (US and Canada): 800.999.6484
Email:

How may we serve you?

Phone (860) 582.9111, Toll-Free (800) 999.6484 (USA & Canada)