Quality system certificates

Please find a selection of our quality certificates below for download:

ISO 13485 Certificate​s

ISO 13485 describes the requirements for a quality system for medical device companies. The ISO 13485 certificates of all manufacturing Fujirebio companies (i.e. Fujirebio Europe N.V., Fujirebio Inc., Fujirebio Diagnostics Inc. and Fujirebio Diagnostics AB) are available below.​

ISO 9001 Certificates

ISO 9001 is the international standard for quality management. Our affiliates (Fujirebio France, Fujirebio Germany, Fujirebio Italy, Fujirebio Spain) comply to ISO 9001 and their certificates are available below. 

MDSAP Certificate​s

The Medical Device Single Audit Program (MDSAP) evaluates if a manufacturer of medical devices is compliant to the regulatory requirements of MDSAP countries (Japan, Australia, Brazil, Canada and US). The MDSAP certificates of all manufacturing Fujirebio companies (i.e. Fujirebio Europe N.V., Fujirebio Inc., Fujirebio Diagnostics Inc. and Fujirebio Diagnostics AB) are available below. 

IVDD and IVDR Certificates

For product specific documentation concerning the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), go to Product documentation.