ISO 13485 Certification.

Osteotech's priority is focused on continual investment in new production technologies, team building in the organization, product quality accuracy and new certifications.

In order to ensure that our focus is on quality and to provide a service that always meets the highest requirements of our customers as well as the requirements of the Medical Device manufacturing sector, Osteotech has sought ISO 13485 Certification.

We want to demonstrate how we are consciously and capablely involved in all stages of the design, development, production, storage and distribution of the medical devices we manufacture. It was also thinking of the recognition of the quality management of our organization that ISO 13485 became a goal to achieve in 2019.

In order to enhance our customers' confidence in the Osteotech production label, this certification and the right to use it after issuing the Certificate of Conformity also ensures sustained access to new international markets, since in order to obtain It is therefore necessary to comply with all regulatory requirements applicable to medical devices and Community directives.

We want to continue to highlight the quality and accuracy of Osteotech Components through the certifications awarded to reflect the continued, significant and sustained increase in market share in the sector.