The Process

The Evaluation Process

NeuroDM was designed to remove the usual barriers to clinical evaluation. Our process guarantees high-level scientific analysis and economic validation in less than a month, thanks to agile governance and streamlined interactions with regulatory authorities (ANSM/CPP).

The Network

Notre Offre

Our Process

Your journey from idea to the operating room

The "Step-by-Step"

7-14 days

Qualification

Submission of your application via our online form.

Verification of completeness by R. Guizem

Submit a project

Strategic Arbitration

Presentation of your project to the Governance Committee

Evaluation of clinical interest and technical feasibility

Engineering & Design

Methodological scoping with the CEDM or the DRCI of the HFAR.

Budget establishment and signing of the agreement

Regulatory Go-Ahead

Submission to authorities (ANSM / CPP) by the DRCI Promotion Department or the DRCI of the HFAR.

Clinical Phase

Opening of centers, inclusions, and monitoring by our dedicated CRAs.

Our Added Value

NeuroDM does more than just evaluate your project; it provides an immediate boost to transform your innovation into clinical reality.

Accelerated Expertise

Reducing Uncertainty, Maximizing Time. In the development of a medical device, every month counts. NeuroDM was specifically designed to remove the administrative and scientific hurdles that traditionally slow down access to the clinical field.

Parallel Engineering

While we evaluate medical relevance, our experts at the CEDM (URC Lariboisière) are already analyzing regulatory and methodological feasibility.

Governance Responsiveness

Your application benefits from a rapid critical analysis by our committees, allowing clinical interest to be validated in record time.

Institutional Fast-Track

This single point of contact centralizes expertise from the AP-HP and the Rothschild Foundation, eliminating unnecessary back-and-forth. You receive a clear diagnosis on the viability of your project and a precise execution schedule, where traditional circuits often impose several months of waiting.

NeuroDM in several phases

The NeuroDM Service Showcase

Your Investigation Catalog

Pre-Market Phase

Post-Market Phase

Objectif: Marquage CE et Preuve de Concept

Études de Faisabilité (First-in-Human)

Première utilisation du dispositif chez l'homme dans un environnement sécurisé.

Investigations Cliniques Pivotales

Études de grande envergure pour démontrer la performance et la sécurité en vue du marquage CE (RDM 2017/745)

Design de Protocole & Méthodologie

Co-rédaction du protocole avec les experts du CEDM et de l’HFAR pour s'assurer que les critères d'évaluation (endpoints) sont solides.

Soumissions Réglementaires :

Gestion complète du dossier ANSM (Autorité de santé) et CPP (Comité de Protection des Personnes).

Accès aux Plateaux Techniques

Utilisation des blocs opératoires de pointe, de l'imagerie interventionnelle et de la robotique dans nos centres d'investigations.

Objectif : Remboursement et Rayonnement

Suivi Clinique Après Commercialisation (PMCF)

Collecte systématique de données cliniques pour confirmer la sécurité à long terme.

Études de "Vraie Vie" (Real World Evidence)

Analyse de l'utilisation du dispositif dans la pratique quotidienne des chirurgiens.

Études Médico-Économiques :

Démontrer l'efficience du dispositif médical pour obtenir un remboursement par la Sécurité Sociale.

Observatoires et Registres

Mise en place de bases de données de suivi de cohortes sur plusieurs années.

Technical Pillars

Institutional Excellence at your service:

Rigor: The Promotion Department of the AP-HP DRCI and the DRCI of the HFAR secure your trials.

Expertise: The CEDM (URC Lariboisière) and the URC of the HFAR optimize your methodology.

Agility: A single point of contact for two institutions (APHP & Rothschild)

Learn more about the network

Human and connected management.

Ready to save time?

Submit your application today for an initial response within 8 days.