Certification
Quality is at Our Core.
At Ultimate NiTi Technologies, 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. We have a stong sense of 'team' and work together, within a tight Quality Management System, to best serve our customers.
We are committed to providing you with high quality service and products that meet your needs. Please contact our Regulatory Department for information regarding our Quality Management System, or you may follow the link below for further information.
Domestic and International Regulatory Compliance and Certification
Quality System for Medical Devices Certification
EN ISO 13485:2003 + AC:2007
Europe - EC Directive 93/42/EEC annex II, Article 3 Quality Assurance System Compliance
EC Directive 93/42/EEC Compliance 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
TUV Rheinland
Product Safety GmbH
Am Grauen Stein
D-51105 Köln, Germany
http://www.tuv.com/us/en/index.html
ISO 13485:2003 certification is audited by
TUV Rheinland
Product Safety GmbH
Am Grauen Stein
D-1105 Köln, Germany
http://www.tuv.com/us/en/index.html
Should you have a quality related question regarding any of our products, contact Ultimate for an immediate response:
Phone: 860.582.9111
Toll free (US and Canada): 800.999.6484
Email: quality@ultimateniti.com
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