Contact

What are you looking for?

ISO 13485 certification services to IVD industry

23. Aug 2024

Our comprehensive range of services helps organizations comply with many international, national, regulatory, and industry standards, and demonstrate their best practices.

We provide accredited certification for IVD reagents and reagent products, calibrators and control materials for clinical chemistry, immunochemistry, hematology, immunohematology, microbiology, infectious immunology, histology/cytology, and genetic testing.

Our 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*). Accreditation demonstrates a certification body’s technical competence, reliability, and integrity.

We have decades of experience, and we operate with the utmost competence and trust, delivering the highest quality service at global and local levels. Our accreditation means that we can certify your processes and products with confidence.

Transparency, independence, and integrity are key to delivering our services. We comply with the highest standards to maintain our accreditations, so you can be sure of our competence.

Contact us:

Kati Lisitsin
Account Manager
+358 (43) 8273155

*) SGS Fimko Oy is a certification body S009, accredited by the FINAS accreditation service, accreditation requirement SFS-EN ISO/IEC 17021-1. You can check our valid accreditation scope from the FINAS website: www.finas.fi

About SGS

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.

News & Insights