Regulatory Compliance

Confidence Built In

At Ultimate, we believe that quality extends beyond our physical products. We are dedicated to ensuring excellence in every aspect of our business, from our interactions with customers and vendors to the development of innovative materials and products. Our commitment to quality is reflected in our strong team dynamic and our adherence to a rigorous Quality Management System, all in order to best serve our valued customers.

If you require any information regarding our Quality Management System or have any inquiries about the safety of our products, our Regulatory Department is available to assist you. Alternatively, you may find the information you seek by following the provided links below.

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.

Regulations, Compliance, & Certificates:

EU ISO 13485 <br />Quality System Certificate
EU ISO 13485
Quality System Certificate
EU Certificates <br />of Registration
EU Certificates
of Registration
Korean GMP <br />Certificate 2025
Korean GMP
Certificate 2025
Japanese Certificate <br />Foreign Manufacturer
Japanese Certificate
Foreign Manufacturer
US <br />FDA Registration
US
FDA Registration
MDD Extension<br />per EU 2023/607
MDD Extension
per EU 2023/607

Safety Data Sheets:

(EU SDS forms are available upon request)

Nickel Titanium Alloy SDS
Nickel Titanium Alloy SDS
Titanium & Titanium Alloys SDS
Titanium & Titanium Alloys SDS
Stainless Steel SDS
Stainless Steel SDS
Thermoplastic Polymer SDS
Thermoplastic Polymer SDS

Quality Links:

Ultimate Wireforms eIFU
Ultimate Wireforms eIFU
Symbols Glossary
Symbols Glossary

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
http://www.medenvoyglobal.com/

Notified Body & MDD (CE) Registration

BSI Group The Netherlands B.V.
Say Building
John M. Keynesplein 9
1066 EP Amsterdam
The Netherlands
https://www.bsigroup.com/nl-NL/

ISO Registration

BSI
Kitemark Court, Davy Avenue
Knowlhill, Milton Keynes MK5 8PP, UK
2595 AM The Hague
The Netherlands
http://medicaldevices.bsigroup.com