In vitro diagnostics (IVD) – extract of our test spectrum

SGS – Your competent partner for in vitro diagnostics testing and certification 

SGS Germany GmbH operates accredited laboratories under DAkkS (ILAC) as well as within the IECEE CB Scheme, ensuring testing at the highest professional standards with international recognition.

In direct collaboration with SGS Fimko, the SGS Group Germany offers comprehensive IVDR certification services. The European Commission has officially recognized SGS Fimko Oy as a Notified Body (NB 0598) under the EU In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

The scope of SGS’s competence covers conformity assessment according to the following IVDR annexes:

• Annex IX, Chapter I: Conformity assessment based on a quality management system (QMS)
• Annex IX, Chapter II: Conformity assessment based on assessment of the technical documentation
• Annex X: Conformity assessment based on type examination
• Annex XI: Conformity assessment based on production quality assurance
  
  This comprehensive designation covers almost all IVD products.

Our experienced testing engineers develop customized test programs and execute test procedures precisely according to the specific requirements.

At our state-of-the-art laboratory in Puchheim, near Munich, we offer a comprehensive range of product safety tests and electromagnetic compatibility (EMC) tests. This ensures that your products meet international standards and are optimally certifiable.

Safety requirements for in vitro diagnostics (IVD)

 EMC requirements for in vitro diagnostics (IVD)

Further information on our services for in vitro diagnostics can be found here.

Contact

Armin Hudetz
t: +49 89 78 74 75-133
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Customer Service Team
t: +49 89 78 74 75-22
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