Certification

TiTaMED Spinal System


FDA Approval

Our covering letter from FDA for our 510(k). (3 pages)


CE

Our Medical Device Directive 93/42/EEC Class IIb CE certificate issued by SGS UK for our Spinal Implant System and Cervical Cages. (1 certificate)

Spinal System CE Certificate

Spinal System CE Certificate

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Quality Management System - Medical Manufacturing


ISO 13485

Our ISO 13485 certificate issued by SGS UK for medical devices and implant manufacturing. (1 certificate)

ISO 13485 Certificate

ISO 13485 Certificate

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Quality Management System - Aerospace Manufacturing


AS9100

Our Aerospace accreditation (AS9100 Rev C) issued by Bureau Veritas. (1 certificate)

For manufacture only, not design.

AS9100 Certificate

AS9100 Certificate

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Quality Management System - General Manufacturing


ISO 9001

Our ISO 9001 certificate issued by SGS UK for general engineering and manufacture. (1 certificate)

ISO 9001 Certificate

ISO 9001 Certificate

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BEE


BEE Level 4

TiTaMED is BEE level 4. (1 certificate)

BEE Certificate

BEE Certificate

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