The AlgOss Biotechnologies production is carried out under compliance with the Austrian Medical Devices Law, the European Directive MDD 93/42/EWG for medical devices and regulations and requirements of the American authorities (FDA).

In 2005 the company’s process oriented quality management system under EN ISO 13485 was successfully certified. All processes from the development to the dispatch are constantly controlled and monitored. Internal and external audits by customers and notified bodies are regularly performed.

The quality management system is ordinarily updated upon new legislative and standard regulations as well as actual scientific findings.

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