M3i
Provider of clinical services and software for medical device and medical AI development. Combines clinical expert networks, usability engineering, data curation and an AI data pipeline to support formative and summative usability evaluation, PMCF studies, annotated training datasets, AI validation workflows, regulatory documentation and training workshops.
Industries
Nr. of Employees
small (1-50)
Products
M3i MxDB
Digital biobank and clinical data acquisition platform offering gold standard training datasets, high-quality annotations, and clinical expert feedback for medical AI development and approval.
MxDB Digital Biobank
Proven processes for clinical data, annotations and clinical evaluation for AI-based innovations.
Clinical Study
Comprehensive clinical study coordination and PMCF study management services to ensure regulatory compliance, including study document preparation, monitoring, and data analysis.
Clinical Study Center
Clinical PMCF studies to ensure your regulatory compliance.
DRIVE.AI
An integrated software platform and development and validation environment for data-driven AI innovations in medical technology, streamlining workflows from idea to regulatory approval.
UsabilityPLUS
Comprehensive clinical components and service platform for user-driven development, formative and summative usability evaluations, and MDR-compliant approval.
M3i MxDB
Digital biobank and clinical data acquisition platform offering gold standard training datasets, high-quality annotations, and clinical expert feedback for medical AI development and approval.
MxDB Digital Biobank
Proven processes for clinical data, annotations and clinical evaluation for AI-based innovations.
Clinical Study
Comprehensive clinical study coordination and PMCF study management services to ensure regulatory compliance, including study document preparation, monitoring, and data analysis.
Clinical Study Center
Clinical PMCF studies to ensure your regulatory compliance.
DRIVE.AI
An integrated software platform and development and validation environment for data-driven AI innovations in medical technology, streamlining workflows from idea to regulatory approval.
UsabilityPLUS
Comprehensive clinical components and service platform for user-driven development, formative and summative usability evaluations, and MDR-compliant approval.
Services
End-to-end usability engineering: formative and summative evaluations, realistic clinical test setups, usability engineering file components, and protocol templates to support regulatory conformity.
Project coordination and contract management with clinical sites, study documentation preparation (protocols, eCRFs), monitoring and data analysis for post-market clinical evidence generation.
Curation, anonymization, secure storage and expert annotation workflows for imaging datasets to produce training and validation data for medical AI, including annotation guideline development and QA.
Web-based platform that integrates raw data extraction, anonymization, annotation, QA, model development and automated documentation generation to accelerate translation from concept to regulatory submission.
Targeted training and seminar programs combining regulatory and usability methods with clinical observation (including operating room visits) to transfer practical clinical knowledge to engineers and product teams.
Consulting on regulatory best practices (including FDA and MDR-related considerations), clinical validation strategies, and project planning for AI-based medical technologies.
End-to-end usability engineering: formative and summative evaluations, realistic clinical test setups, usability engineering file components, and protocol templates to support regulatory conformity.
Project coordination and contract management with clinical sites, study documentation preparation (protocols, eCRFs), monitoring and data analysis for post-market clinical evidence generation.
Curation, anonymization, secure storage and expert annotation workflows for imaging datasets to produce training and validation data for medical AI, including annotation guideline development and QA.
Web-based platform that integrates raw data extraction, anonymization, annotation, QA, model development and automated documentation generation to accelerate translation from concept to regulatory submission.
Targeted training and seminar programs combining regulatory and usability methods with clinical observation (including operating room visits) to transfer practical clinical knowledge to engineers and product teams.
Consulting on regulatory best practices (including FDA and MDR-related considerations), clinical validation strategies, and project planning for AI-based medical technologies.
Expertise Areas
- Usability engineering and IEC 62366 compliance
- Clinical study management and PMCF execution
- Medical AI data curation and annotation
- Integrated AI development and validation workflows
Key Technologies
- Medical image annotation and segmentation
- Automated de-identification (anonymization)
- Service-oriented web architecture for AI data pipelines
- Clinical data integration and exchange frameworks
News & Updates
Thought-leadership article summarizing expert views on robotics, AI and usability in minimally invasive surgery.
Comparative evaluation of medical image segmentation tools and guidance on tool selection for annotation projects.
White paper summarizing a user study performed to verify a video management system, including study setup, participant profiles and data collection methods.
Development of an integrated AI development and validation platform funded by a Bavarian innovation funding agency.
Referenced certificate indicating adherence to ISO 13485 quality management processes for medical devices.
Downloadable summative usability test protocol aligned with MDR and IEC 62366.
Thought-leadership article summarizing expert views on robotics, AI and usability in minimally invasive surgery.
Comparative evaluation of medical image segmentation tools and guidance on tool selection for annotation projects.
White paper summarizing a user study performed to verify a video management system, including study setup, participant profiles and data collection methods.
Development of an integrated AI development and validation platform funded by a Bavarian innovation funding agency.
Referenced certificate indicating adherence to ISO 13485 quality management processes for medical devices.
Downloadable summative usability test protocol aligned with MDR and IEC 62366.