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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
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
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
http://www.medenvoyglobal.com/
Notified Body & MDD (CE) Registration
BSI Group The Netherlands B.V.
Say Building
John M. Keynesplein 9
1066 EP Amsterdam
https://www.bsigroup.com/nl-NL/
ISO Registration
BSI
Kitemark Court, Davy Avenue
Knowlhill, Milton Keynes MK5 8PP, UK
http://medicaldevices.bsigroup.com
Europe - EC Directive 93/42/EEC Annex II excluding Section 4
EC Directive 93/42/EEC Compliance Certificate
Quality Links
Ultimate Wireforms eIFUSymbols 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
Email: