Preclinical Evaluation: proof of concept before the patient.

We plan and manage your device's preclinical strategy - bench tests, performance testing and in vivo studies - to generate the safety and functional evidence required before clinical stages and registration.

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Preclinical Evaluation: proof of concept before the patient.
What we deliver

We define and coordinate the preclinical studies that support the technical dossier.

  1. Definition of the preclinical plan based on risk analysis.

  2. Performance and bench testing under product-specific standards.

  3. In vivo studies (where applicable) and selection of laboratories/CROs.

  4. Critical appraisal of results and integration into the technical dossier.

  5. Rationale for progression to the clinical phase.

Deliverables

What you receive

A preclinical evaluation plan.
Test protocols and reports.
A preclinical summary integrated into the technical dossier.
An assessment of whether the evidence is sufficient to proceed to the clinical phase.
References

Reference standards

  • ISO 10993 series - biological evaluation, where applicable.
  • Performance standards specific to each product family (IEC/ISO/ABNT NBR).
  • Good laboratory practices applicable to the studies.
FAQ

Frequently asked questions

Let's talk

Before the patient comes preclinical evidence.

We structure the studies that support your dossier.

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