Quality & Regulations
Certified French quality
Global D’s quality system is certified NF EN ISO 13485 in accordance with the Medical Devices Directive(93/42/CEE) Global D products (dental implants, orthodontic and maxillofacial products, prosthetic systems and instruments) all haveCE marking. To maintain an optimum quality level, we have chosen one of the most demanding French certification bodies, LNE/GMED.This internationally recognised organisation certifies our quality system and the products in our ranges.
Global D’s engineering department, which currently comprises 6 engineers, provides advice and immediate answers to your questions. Our desire to meet your requirements, our rigorous standards and the importance we attach to the choice of materials and technologies used give you the assurance of certified concepts and peace of mind for your patients.
To ensure the effectiveness of our implants and that they are tolerated well, every implant that is supplied is manufactured and inspected using the latest technologies and the most rigorous processes.
Our implants are designed as integrated systems andnone of their components can be replaced byone from another source.
Certifications and approvals
2013 : Canadian approval obtained for the In-Kone® range dental implant system (In-Kone® Universal SA² implants, prosthetic parts and associated instrumentation)
2003 : 510(k) notification obtained for the ORTRAUTEK TRAUMA SYSTEM range of maxillofacial osteosynthesis devices
2003 : 510(k) notification obtained for the ORTRAUTEK ORTHOGNATHIC SYSTEM range of maxillofacial osteosynthesis devices
Please contact Global D for the full list of devices concerned by these approvals.
Quality management system:
NF EN ISO 13485:2012/ISO 13485:2003 quality management system certified as compliant with the Canadian (CMDCAS) and Taiwan (TCP) requirements.
ISO 13485 compliance established by LNE – GMED (0459).