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 will utilize a risk-based process approach to the appropriate processes in order to 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
ISO 13485:2016 & EN ISO 13485:2016

US FDA Establishment Registration and Device Listing

Europe - EC Directive 93/42/EEC Annex II excluding Section 4
EC Directive 93/42/EEC Compliance Certificate

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

Notified Body/Registrar/Certification Bodies

Regulatory Affairs Incident Reporting
MedEnvoy Global B.V. (EU Authorized Representative)
Prinses Margrietplantsoen 33-Suite 123
2595 AM The Hague
The Netherlands

Notified Body & MDD (CE) Registration
BSI Group The Netherlands B.V.
Say Building
John M. Keynesplein 9
1066 EP Amsterdam

ISO Registration
Kitemark Court, Davy Avenue
Knowlhill, Milton Keynes MK5 8PP, UK

Europe - EC Directive 93/42/EEC Annex II excluding Section 4
EC Directive 93/42/EEC Compliance Certificate

Quality Links

Ultimate Wireforms eIFU
Symbols Glossary

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

For over 30 years, our relationships have been built on integrity and a consistent focus on Quality, Service, Innovation, and Support.

Let's Form the Future!

Phone 860.582.9111, Toll-Free 800.999.6484 (USA & Canada)