The company Quality System is certified ISO 13485:2016.
SmartBone® and SwissBone® are CE marked according to 93/42/EEC Medical Device Directive and its following amendments and modifications:
SmartBone® On Demand ™ is MDR certificated according to the Medical Device Regulation 2017/745 for dental and orthopaedics indications.
The bovine bones used to produce SmartBone® and SwissBone® come from certified Bovine spongiform encephalopathy (BSE) free bovine breedings.
The bovine bone washing and cleaning is performed at low-temperature through a multi-step chemical process: the material is hence not ceramic-like, but a natural material conserving the optimal mechanical properties of a bovine-originated mineral structure.
Moreover, the process inactivates pathogens and removes the unwanted materials, such as cells, antigens and viruses.
The Medical Device is subjected to different sterilization processes depending on the type of the packaging:
Both methods are safe and reliable and duly validated.