Quality / Regulatory Documents

Important information 

Read about Company name and Notified body change in the Official Statement

Declaration of Conformity Olerup QTYPE 11      View
Declaration of Conformity SCORE 6      View
Declaration of Conformity IVD General      View
Declaration of Conformity Olerup SSP IVD Annex II List B      View
CareDx AB ISO 13485 Certificate      View
CareDx AB IVDD Product Certificate      View
CareDx AB MSDAP Certificate      View
CareDx Pty ISO 13485:2016 Certificate      View