ETB-BISLIFE’s work methods comply with European directive 2004/23 and its annexes, the Dutch Body Material (Safety and Quality) Act (WVKL) and the Body Material Requirements Decree (Eisenbesluit Lichaamsmateriaal).
ETB-BISLIFE is recognised as an Organ Bank (8085 and 8086) and is regularly inspected on the basis of the Wet veiligheid en kwaliteit lichaamsmateriaal (Wvkl) (Bodily Material Quality Safety Act) by the Healthcare and Youth Inspectorate.
Continuous improvement and secured implementation processes ensure that changes are embedded in the organisation and that the organisation continues to comply with laws and regulations.
We also regularly host audits by other tissue banks and an external institution accredited for our ISO 9001 certification.
Concerning the tissue types corneas, skin, heart valves , blood vessels and tendons, ETB-BISLIFE fulfils the requirements of the German Medicinal Products Act (Arzneimittelgesetz) and Human Tissue Act (Gewebegesetz). The permit issued by the German authorities (i.e. the Paul Ehrlich Institute [PEI]) allows us to supply these tissues to German hospitals.
ETB-BISLIFE has also registered various skin and bone tissues via its distributors with the Ministry of Food and Drug Administration (MFDS) in South Korea.
In addition to internal audits within our own organisation, ETB-BISLIFE periodically conducts audits for external partners, including other tissue banks and suppliers of critical materials or services.