Our services for Digital Medical Devices (DMD)

Optimize the Medical Device (MD) scope and risk classification of your software thanks to our pragmatic approach.

Is your SaMD already FDA approved? We help you navigate the gap between the FDA and MDR requirements and check all European conformity requirements.

Optimize your Quality Management System (QMS) of your Software as Medical Device (SaMD) at lower cost with JIRA and Confluence. 

Ensure compliance and operational excellence with our internal audit services, meticulously aligning your processes to industry standards.

Achieve CE Marking compliance under MDR 2017/745 with our dual approach: we either guide your journey every step of the way or directly fulfill the necessary requirements for you.