IN-HOUSE PRODUCTS FOR IN VITRO DIAGNOSTICS*

Do you use in-house products for in vitro diagnostics?

From 26 May 2024, the new mandatory regulation for clinical laboratories will come into force.

Clinical laboratories are exempt from complying with the new IVDR regulations, except when they use in-house tests to make a diagnosis. In this case, they will have to comply with the following regulations:

-Art. 5.5 of IVDR
-Annex I of IVDR
-Art. 9 of Real Decreto …./2022

What can we do for you?

300K Consulting helps you in:

Implementation of ISO 15189 for clinical laboratories

Implementation of ISO 13485 for medical devices

General Safety and Performance Requirements (GSPR)

Drafting and compilation of technical documentation of in-house products

 

Justification for the manufacture and use of in-house products

Identification and implementation of applicable standards, technical reference documents and procedures

*NOTE: This service is only available in Spain. 

Our team of professionals is ready to listen and assist you

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