CRO & IVDR · Performance Evaluation
IVD Performance Studies
Plan and execute IVD performance work around the intended purpose. We connect study design, sites, samples, data management and reporting in one agreed protocol.
When this service helps
For evidence gaps identified during regulatory review, method comparisons, clinical performance questions or user studies. Feasibility is assessed before recruitment or sample collection.
Scope of work
Scientific and analytical evidence
Literature assessment, precision, detection capability, interference and method comparison selected for the device claims.
Clinical performance and usability
Define the population, endpoints, comparator and sample size; include intended users and use settings when relevant.
Study operations
Site feasibility, applicable approvals, sample logistics, monitoring, data review and statistical analysis.
What you receive
- Protocol and analysis plan
- A defined question, endpoints, methods, acceptance criteria and responsibilities.
- Study report and data package
- Results and limitations linked to the protocol and source records, ready for performance evaluation.
What to prepare
Intended purpose and IFU; available studies; assay and specimen requirements; instrument availability; proposed endpoints; target dates and any notified-body feedback.