Our quality system

Liofilchem is certified by TÜV Süd to ISO 9001 for the quality management, to ISO 13485 as manufacturer of IVD (in-vitro diagnostics medical device) and to the MDSAP scheme (Medical Device Single Audit Program) for the sale of IVD (in-vitro diagnostic medical devices) in Australia, Brazil, Canada, Japan and the United States.

Liofilchem has obtained the EU Quality Management System Certificate (IVDR) pursuant to Regulation (EU) 2017/746 on in-vitro Diagnostic Medical Devices, Annex IX Chapters I and III (Class C and B Devices excluding self/near-patient-testing and Companion Diagnostics).