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).
EU Quality Management System Certificate (IVDR)
The Liofilchem's Quality Management System is certified by TÜV Süd to the Regulation (EU) 2017/746 on in-vitro Diagnostic Medical Devices for the manufacturing of Class C and B in-vitro Diagnostic Medical Devices.
ISO 13485:2016 MDSAP
Liofilchem's Quality Management System is certified by Tüv Süd America Inc. according to the MDSAP scheme for design, development, manufacture and distribution of IVD (In Vitro Diagnostic Medical Devices) in Australia, Brazil, Canada, Japan and United States.
UNI EN ISO 13485:2016
Liofilchem manufactures In Vitro Medical Diagnostic Devices conform to the use destination provided for and current regulation requirements.
Liofilchem has implemented an “Occupational Health and Safety Management System” which fullfils the requirements of the standard ISO 45001, to control risks in this regard and to improve its performance.