A well-structured Quality Management System (QMS) is fundamental to ensuring regulatory compliance, process efficiency, and medical device safety throughout its lifecycle. Even if formal certification like ISO 13485 is not yet required, it is crucial to ensure that the organization has a coherent system adapted to legal requirements.

We provide technical and strategic support in creating, organizing, and improving quality systems, focusing on documentation, internal processes, and best practices to ensure compliance with the MDR (Regulation (EU) 2017/745), IVDR (Regulation (EU) 2017/746), and other applicable standards.