We are happy to announce that our certification body SGS Fimko is now able to provide FINAS accredited ISO 13485:2016 certification services to in vitro diagnostic (IVD) industry, after successfully extending their ISO 13485:2016 scope to also cover IVD technical areas.
Furthermore, SGS Fimko is awaiting designation for the IVDR (EU) 2017/746 Notified Body status by Q1/2025.
Together with SGS Fimko, we provide accredited certification from Germany for IVD reagents and reagent products, calibrators and control materials for clinical chemistry, immunochemistry, hematology, immunohematology, microbiology, infectious immunology, histology/cytology, and genetic testing.
The scope also covers IVD diagnostic instruments and software, as well as sample receptacles (including sterile), chromatographic methods, and microscopy.
Why choose ISO 13485 certification from SGS?
SGS Fimko’s certification services are accredited by FINAS Finnish Accreditation Service. Accreditation demonstrates a certification body’s technical competence, reliability, and integrity.
SGS Fimko’s full accreditation scope as certification body (S009) can be seen on the FINAS website at SGS Fimko Oy (finas.fi)
This email address is being protected from spambots. You need JavaScript enabled to view it. for further explanations concerning the ISO 13485 certification process for IVD. We will respond immediately.
Contact
Armin Hudetz
t: +49 89 787475-133
f: +49 89 12504064-133
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Customer Service Team
t: +49 89 787475-222
f: +49 89 12504064-100
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