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GDT Implants is a regulated manufacturing facility that complies with strict international quality standards and takes exceptional care in obtaining certification for its products, which are distributed across the world.
GDT Implants is in full compliance with all European directive for Medical Device Directive (93/42/EEC) and ISO 13485:2016. Our facility is inspected on a regular basis with routine audits by international auditors.
GDT Implants is certified to operate within the USA, successfully established the FDA Medical Devices Registration, and obtain the FDA 510(k) approval for certain implant products.
We have invested a significant amount of resources to ensure that we maintain high quality in our manufacturing processes.
GDT Implants has gained and works according to the following standards: