Since 1996, the productive procedure was certified according to the requirements of the Quality Inspection System ISO-9001 and complied fully with the Common Harmonized Technical Standards by European Pharmacopeia (CE mark –_cc781905-5cde-3194- bb3b-136bad5cf58d_directive 93/42/EC). The entity certifying the company MEDIPAC - Th. KAZANTZIDIS SA is EKEVYL (Research Center for Biomaterials Inc.) which is a notified body by the European Union and certifies to annual inspections to demonstrate continued compliance with the applicable system requirements of the standard by: ISO9001, ISO13485.