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- Certificate No. Q5 115756 0001 Rev. 00
Certificate No. Q5 115756 0001 Rev. 00
Certificate No. Q5 115756 0001 Rev. 00
Certificate Overview
This document is a certificate issued by TUV SUD Product Service GmbH, certifying that Titan Medical USA, Inc. has established and maintains a quality management system compliant with the standard ISO 13485:2016, which pertains to medical devices quality management systems for regulatory purposes.
Holder and Facility Details
- Company: Titan Medical USA, Inc.
- Address: 6350 Quadrangle Drive, Suite 120, Chapel Hill, NC 27517, USA
Scope of Certification
The certification covers the design and development of computer-controlled, robotically-assisted surgical devices.
Standards Applied
- EN ISO 13485:2016
- DIN EN ISO 13485:2016
Certification Details
- Certificate Number: Q5 115756 0001 Rev. 00
- Report Number: 72172918
- Valid From: July 14, 2022
- Valid Until: January 27, 2023
Certification Authority
Issued by TUV SUD Product Service GmbH, Ridlerstraße 65, 80339 Munich, Germany. The certificate is signed by Christoph Dicks, Head of Certification/Notified Body.
Additional Information
Further details and certificate validity can be verified at the TUV SUD certification website: tuvsud.com/ps-cert.
Catalog excerpts
(( DAKKS Deutsche Akkreditierungsstelle D-ZM-11321-01-00 Product Service Certificate No. Q5 115756 0001 Rev. 00 Holder of Certificate: Titan Medical USA, Inc. 6350 Quadrangle Drive, Suite 120 Titan Medical USA, Inc. 6350 Quadrangle Drive, Suite 120, Chapel Hill NC 27517, USA See Scope of Certificate Certification Mark: Applied Standard(s): Medical devices - Quality management systems Requirements for regulatory purposes Design and Development of Computer- controlled, Robotically-assisted Surgical The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system, which meets the requirements of the listed standard(s). All applicable requirements of the testing and certification regulation of TUV SUD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?qg=cert:Q5 115756 0001 Report No.: Valid from: Valid until: Head of Certification/Notified Body TUV SUD Product Service GmbH + Certification Body * Ridlerstrale 65 * 80339 Munich * Germany
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