Ovogene confirms that all our donor related processes such as donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells fully comply with the highest European standards - Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004.
Ovogene follows all the quality requirements of international ISO 9001 standard in our daily work by implementing Standard Operation Procedures for all critical donor related steps from donor recruitment to transport of cryopreserved biological materials worldwide including traceability and witnessing for all the donor samples on every stage of its processing.
We perform annual internal audits of all our processes, implement a procedure for nonconformance management and a risk management approach in all our processes and procedures. We are proud to declare that our company fully complies with European IVF standards as well as with the FDA, Health Canada, HFEA, ANVIZA, ANZICA and other requirements. We ensure compliance with the highest world IVF standards in every step of our activities.
