Chloé Fattebert

At Neurosoft Bioelectronics, we are building minimally invasive brain interfaces to monitor, treat, and restore lost functions for individuals fighting neurological disorders. We have pioneered the development of soft, elastic brain interfaces that offer enhanced bio-integration and minimize the mechanical mismatch with neural tissues. Our brain interfaces are 1000 to 100’000 times softer, and 3 to 5 times thinner compared to alternative solutions. These unique mechanical properties provide a significant improvement in the safety profile. Brain-Computer Interfaces (BCIs) manufactured with our technology do not only have the potential to reduce scar tissue formation, which has been one of the main bottlenecks in the development of long-term BCIs, but to reduce other risks such as subdural hematomas and brain compression. Moreover, our interfaces can access sulci and enable minimally invasive brain implantation, as they can be folded and unfolded in extreme form factors without risk of being damaged. My key tasks: - Implement and maintain a smart and agile Quality Management System, while staying in compliance with QMSR and ISO 13485 requirements. It is one of the challenge of working in start-up environment quickly evolving. - Define Regulatory Strategies to ensure efficient and rapid market access. - Communicate with EU and US Authorities for audits and files submissions. - Manage suppliers and support production in house with quality insights. In summary, I cover all aspects of quality assurance, from documentation control, supplier management, and internal/external audits to non-conformity and CAPA procedures, sterility assurance, and batch release. Additionally, I actively support regulatory submissions (CE marking, FDA approvals) and integrate regulatory requirements into product development, risk management, and design control. We also recently transferred our paper based QMS to an eQMS, performing the Software validation with a Risk based approach.

PRRC and Management Representative for the company. Product portfolio including Class I and IIa Medical Devices in endodontics. Team Management (6 people). Worldwide Market Registration - QMS & Technical Documentation - MDR Transition project (QMS and products compliance) - Change Control - Suppliers audit - MDSAP implementation Project.

Regulatory & Clinical Affairs, Quality Management for Medical Devices & IVD's. ISO 13485, MDR, IVDR, Internal Audit of QMS, Supplier Audit, PMS, Vigilance, CAPA, Complaint Handling. Team Leader for the on-boarding of new people joining the company and management of a team of 5 co-workers. QA & RA Track record: • Implementation, deployment and upgrade of Quality Management Systems based on EN ISO 13485:2016 for various manufacturers of MD and AIMD. • Technical and manufacturing documentation based on the MDD 93/42/EEC and AIMDD 90/385/EEC. • Providing trainings on ISO 13485:2016, QMS implementation, internal and suppliers’ audit. • Creation of MDR gap analyses and transition action plans for manufacturers. • Implementation of Risk Management Files based on the ISO 14971:2012 for class I and IIa devices (active & non-active MD). • Internal and suppliers’ audits based on ISO 9001:2015 and ISO 13485:2016 (>50 audit days). • Acting as Quality and Regulatory Manager (part-time) for a start-up with Class IIa CE Marked products on the market in the IVF/ART field. • Improvement of the servicing process and qualification of service providers to handle the maintenance of enteral nutrition pumps worldwide. • Support for the creation of labels and IFU's for Class I, Is and IIa Medical Devices. • Coached and supported a multi-national company for the improvement system (Corrective and Preventive Actions, Engineering Change Records, Complaints, Failure Investigations).

Regulatory & Clinical Affairs. Quality Management. ISO 13485. Medical Devices.

- Création, mise en oeuvre et validation des nouveaux processus de fabrication accompagnés de la documentation nécessaire (rapports de validation, protocoles et instructions de travail) - Gestion des opérations pilotes de fabrication - Anticipation et résolution des problèmes durant le processus de production et optimisation de la production pour en améliorer le rendement - Soutien au département de Recherche et Développement dans la conception pour la fabrication - Transfert du nouveau développement au secteur manufacturier . Validation des produits conformes aux normes de conception - Gestion des essais et de I'inspection de matériaux entrants - ldentification et gestion des nouveaux équipements nécessaires à la fabrication du produit - Révision de la pertinence de la documentation présentée par le secteur manufacturier - Organisation des opérations de fabrication conformément aux normes du système qualité - Soutien au département d'Assurance Qualité dans la documentation des procédés de fabrication - Contribution et maintien à l'amélioration du système de qualité afin d'être en conformité avec les normes réglementaires, en particulier la norme ISO 13485.

Support for production, logistics and engineering. Coordination of internal and external stakeholders. Organization and updating of operating ranges and documentation.

Taking intensive English courses to obtain the CAE certificate

Teaching and helping several students and schoolchildren with homeworks in mathematics, sciences, french, english and german.

Taking part in the Innokick project. The aim is to offer a creative and innovative product to a start-up using Marketing and Innovation skills learned during the course.

Réalisation de documentation technique Commande de pièces Conception et mise en place d'outillage spécifique