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M3i – Enabling Clinical Innovation

We provide you with the regulatory data required for the development,
approval and market surveillance of your medical products.

Our Solutions

Quick and easy access – clinical experts, realistic test environments, clinical data


IEC 62366-1 and FDA compliant evaluation as a factor for success in the development and approval of medical devices.

MxDB Digital Biobank

Proven processes for clinical data, annotations and clinical evaluation for AI-based innovations.

Clinical Study Center

Clinical PMCF studies to ensure your regulatory compliance.

Our Partners & Customers

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Our Advisory Services

We offer workshops and seminars to transfer our knowledge from various project in the field of usability, AI development & approval and PMCF study coordination.

MedTech BaseCamp

Proven quality management processes for the approval of medical devices.

Join our workshop to learn how to design efficient QM processes (DIN 13485) for accelerated product development and approval.

Price: 1.800 €

Usability BaseCamp

Proven processes for standards-compliant usability evaluation of medical devices

This workshop provides practical user-centered development processes, including expert involvement and compliant usability evaluations.

Price: 3.000 €

Regulatory AI BaseCamp

Proven processes for approval of medical AI.

Learn proven QM processes for developing and approving AI innovations. Learn essential regulatory basics and data practices to ensure compliance and successful project outcomes.

Price: 3.000 €

PMCF BaseCamp

Valuable insights in PMCF Plan creation and implementation.

Our workshop offers insights on planning cost-effective PMCF studies that minimize risks and pitfalls, including an introduction to the study application process and contractual agreements with study centers.

Price: 3.000 €

Industry&Clinic Cooperation

Design successful research collaborations between industry & clinic.

Our workshop provides valuable insights into the conditions and contract processes necessary for successful hospital-industry research collaborations.

Price: 1.700 €

Surgical Experience for Engineers (SEE)

Exclusive insights into clinical practice (2-days).

Observe surgical procedures and gain exclusive insights into clinical routines and challenges faced by clinicians in our seminar for healthcare professionals.

Price: 1.200 € pp