Certification & Legal Framework

Certification & Legal Framework
Osteocell follows a strict set of opration procedures which is regulated by the National and European Community legislative framework.

More specifically the company applies a Quality Assurance System in accordance with the international standard ISO 9001:2015.

In the Qualtiy Assurance System all the requirements according to the following have been incorporated and certified:

1. Ministerial Decision ΔΥ8δ/ΓΠ/οικ.1348/04 (Government Gazette 32 Β/16-1-2004): Principles and guidelines for correct practice in the distribution of medical devices
2. Presidential Decree 26/2008 of the Hellenic Republic: Transposition into the Greek legislation of EC directives 2004/23 (Standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells) and the relevant to it 2006/86/EC and 2006/17/EC (Traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells)
3. Presidential Decree 129/2016: Transposition of directives 2015/565, 2015/566 and modification of Presidential Decree 26/2008