Clinical Research: investigations conducted under the right good practices.

We plan and manage clinical investigations with medical devices under RDC 837/2023, ISO 14155:2020 and MDR 2017/745, from the protocol and Medical Device Clinical Investigation Dossier (DICD) to ethics/regulatory submissions and monitoring.

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Clinical Research: investigations conducted under the right good practices.
What we deliver

We cover the clinical investigation lifecycle with good practice governance.

  1. Study design and preparation of the protocol and investigator's brochure.

  2. Preparation and submission of the DICD to ANVISA and the application to CEP/CONEP.

  3. Selection of sites and investigators; contracts and essential documents.

  4. Clinical monitoring and management of deviations, adverse events and data.

  5. A final clinical investigation report to support registration.

Deliverables

What you receive

A clinical investigation protocol and investigator's brochure.
DICD submitted to ANVISA and an ethics dossier (CEP/CONEP).
A monitoring plan and follow-up reports.
A final clinical investigation report.
References

Reference standards

  • RDC 837/2023 - clinical investigations with medical devices (effective from 4 January 2024).
  • ISO 14155:2020 - good clinical practice for device investigations.
  • MDR 2017/745 and CNS/CONEP resolutions for research involving human participants.
FAQ

Frequently asked questions

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Planning to generate clinical data to register your device?

We manage the investigation under RDC 837/2023 and ISO 14155.

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