Le projet Atlantic KET Med soutient les PME et les start-ups utilisant les technologies clés génériques (KET) pour produire des dispositifs médicaux de nouvelle génération.
Un système de gestion de la qualité a été conçu et construit, permettant aux PME de mettre en œuvre et de maintenir un système de gestion de la qualité GMP à partir de zéro.
The Atlantic KET Med Project is bringing new, high tech, pilot production capacity to the EU Atlantic Area in support of SMEs and start-ups using the Key Enabling Technologies (KETs) to produce next generation medical devices. As part of the project, Atlantic KET Med is delivering a rigorous quality management framework to enable SMEs to build and maintain their own GMP Quality Management System (QMS).
A GMP Quality Management System has been designed and built, providing a transferable framework to enable SMEs to implement and maintain a GMP QMS from scratch.
The QMS is designed to utilise a series of templates to ensure that all relevant information is gathered for GMP compliance, and it addresses the needs of global regulations as defined by national and regional regulatory authorities such as the EU (EMA) and the US (FDA). By getting started early with a Quality Management System, you can proactively ensure that your product development programme will fulfil the needs of these regulations and standards, and avoid costly remediation and repeat work.
Si vous souhaitez en savoir plus sur le QMS, n’hésitez pas à aller sur le site web du projet et de prendre contact avec Jessica Walker, walker@atlanpole.fr