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Medical Regulatory Process

Description de l'entreprise

Spentys is an interactive 3D printing platform for orthopaedic medical devices. Spentys aims to reduce the gap between the complexity of the 3D printing technology and the reality of the hospitals environments. The Spentys solution goes from the 3D scanning of the patient's limb, to the 3D modelling and the 3D printing of the patient's specific cast. This solution is completely automatic and centralised on a cloud platform. It makes the process easy to use for physicians and helps them to quickly interact with the Spentys team. This solution makes the 3D printing technology directly available in the hospitals environment, and so to the patients.

Description de la fonction

The objectives of the intern is to lead the medical regulatory process, to go on the market with a custom made medical device of class 1, no sterile. The European certification path should be followed, with a focus on the Belgian Reimbursement Market (AFMPS – Belgian federal institution that is responsible of the “go-to-market” certification process for medical devices).

During the internship, the intern will have to understand all steps of the Spentys solution (from the 3D scanning to the 3D printing), analyse it, and define the protocols that need to be installed, in order to respect the medical regulations. The “Quality Management System” ISO13485 should be our guidelines. Other European rules (ISO10993, 11197, 14971, etc.) also need to be followed. The student will be assisted and coached by a Regulatory Manager.

Profil recherché


To write medical protocol for the production, infrastructure and development

To establish a quality management system in the company (many SOP to develop)

To lead medical tests (biocompatibility, etc.): contacts laboratories (NAMSA)

To be up to date with the new certifications

To stay in contact and follow the advices of our medical consulting team (Covartim)

Background required

To be creative, motivated and resourceful

Knowledge of the medical regulatory system is mandatory

Knowledge of the 3D printing technologies is a plus

To fluently speak/write/understand English

To like being responsible and independent (take initiatives)

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Uniquement pour étudiants de l'enseignement supérieur

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