QA/Regulatory Affairs

QA (Quality Assurance), RA (Regulatory Affairs), RP (Responsible Person for Wholesale Licence) at XVIVO are to be contacted via the XVIVO switchboard with the phone number +46 31 788 21 50.

Quality Assurance & Regulatory Affairs Manager
Mrs Katrin Gisselfält

Contact details

About Quality
XVIVO Perfusion has implemented a Quality Management System to comply with the international standard, ISO 13485:2016, and with local regulations for the Medical Device where our products are sold.

We are certified according to ISO 13485:2016 and we are regularly inspected by authorities to show compliance with the regulations.

Our products are CE marked and have regulatory approvals in countries where they are sold.