Quality system certificates

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.​

Fujirebio Europe ISO 13485 : 2016 certificate (pdf, 1.36 mb)
Fujirebio Inc ISO 13485 certificate (pdf, 352.30 kb)
Fujirebio Diagnostics Inc Pennsylvania - ISO 13485 2016 (pdf, 1.41 mb)
Fujirebio Diagnostics Inc Texas - ISO 13485 2016 (pdf, 458.03 kb)
Fujirebio Diagnostics AB ISO 13485 : 2016 certificate (pdf, 862.41 kb)

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. 

Fujirebio France ISO 9001 : 2015 certificate (pdf, 847.79 kb)
Fujirebio Germany ISO 9001 : 2015 Certificate (pdf, 287.01 kb)
Fujirebio Italy ISO 9001:2015 certificate (pdf, 836.36 kb)
Fujirebio Spain ISO 9001 : 2015 certificate (pdf, 836.44 kb)

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. 

Fujirebio Europe MDSAP N 35087 rev3 (pdf, 528.25 kb)
Fujirebio Inc MDSAP Certificate (pdf, 1.49 mb)
Fujirebio Diagnostics Inc ISO 13485 2016 MDSAP (pdf, 526.67 kb)
Fujirebio Diagnostics AB MDSAP Certificate (pdf, 944.45 kb)

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.

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