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
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
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
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
BEE
BEE Level 4
TiTaMED is BEE level 4. (1 certificate)
BEE Certificate
