Our utmost priority is highest quality throughout.
Therefore, our integrated quality system goes far beyond the fulfilment of official and legal requirements.
In order to meet the regulatory requirements in product development and implementation, we are certified according to international standards, i.e. ISO 9001, ISO 13485 (medical devices) and ISO 15378 (primary packaging for medicinal products).
Our extensive risk management system and a reliably functioning change control process form the framework for successful and secure product development and production.
Since 2013, we have been registered as a tissue bank in accordance with the Federal Law on the Safety of Health Care at the Federal Office of Public Health (BASG/AGES). This allows us the filling, packaging, labelling and storage of bone tissue.
EN ISO 9001
EN ISO 13485
EN ISO 15378
Tissue bank acc. § 22 Austrian Tissue Safety Act
If you need PDF files of our certificates, please contact us: