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 MDSAP Certificate | View |
| CareDx Pty ISO 13485:2016 Certificate | View |