Compliance & quality
Mobiolink is a workflow and traceability tool — not an in-vitro diagnostic device.
Outside the IVDR scope
- Mobiolink makes no diagnosis itself: the final release stays under the lab's human responsibility.
- Mobiolink processes results from CE-IVD marked tests and documents the operations.
Accreditation
- Chronological, sample-specific traceability (reagent lots, operators, equipment).
- Directly usable for ISO 15189:2022 / DAkkS / RiliBÄK.