The certification of the animals from which the raw material comes are originally raised, fed and slaughtered within the territory of the Argentine Republic. The raw material is kept stored in freezers with installed thermal controllers that ensure the storage conditions and keep the pig tissue within the parameters established in the product monograph.

Verification and validation reports demonstrate that the device meets predetermined performance requirements. Clinical evidence is included in the product development process and demonstrates that the device is suitable for its intended use.

Risk Analysis was used in all design phases to ensure that safety principles were adequately addressed. This includes design, protection, and the tests necessary to demonstrate successful implementation. The instructions for use inform users of residual risks.

OstiumMAX Cover sterile collagen resorbable membrane is packaged in non-reusable PVC / aluminum primary packaging. Its characteristics of high chemical resistance, neutrality, density and hardness, allow great inactivity with the content, and in turn, a high insulation barrier with the outside. In the secondary PET packaging, the contained product is clearly identified with a label.

To keep the medical product sterile until implantation, OstiumMAX Cover comes in triple packs. The product in its primary and secondary packaging are sterilized with gamma irradiation. This sterile system (Contents – 1st primary container – 2nd secondary container) allows the authorized professional, together with a suitable surgical field and good implantation practices, to provide the appropriate aseptic conditions for a successful surgery.

OstiumMAX Cover is presented as a single-dose container in such a way that it can be used only once, preventing it from being reused in another instance.