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
MxDB Digital Biobank
A digital biobank providing clinical data, annotations, and evaluation processes for developing and validating AI-based medical technologies.
Clinical Study Coordination
Coordination and management of clinical Post-Market Clinical Follow-up (PMCF) studies to ensure regulatory compliance for medical devices.
UsabilityPLUS
A usability service offering clinical expert panels, realistic test environments, and usability evaluations for medical device development and approval.
DRIVE.AI Platform
A web-based integrated software platform that consolidates AI development steps from idea to regulatory approval for medical imaging applications.
Advisory Workshops and Seminars
Workshops and seminars providing knowledge transfer on usability, AI development and approval, PMCF study coordination, and industry-clinic cooperation.
MxDB Digital Biobank
A digital biobank providing clinical data, annotations, and evaluation processes for developing and validating AI-based medical technologies.
Clinical Study Coordination
Coordination and management of clinical Post-Market Clinical Follow-up (PMCF) studies to ensure regulatory compliance for medical devices.
UsabilityPLUS
A usability service offering clinical expert panels, realistic test environments, and usability evaluations for medical device development and approval.
DRIVE.AI Platform
A web-based integrated software platform that consolidates AI development steps from idea to regulatory approval for medical imaging applications.
Advisory Workshops and Seminars
Workshops and seminars providing knowledge transfer on usability, AI development and approval, PMCF study coordination, and industry-clinic cooperation.
Services
Usability engineering and evaluation 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.
Clinical study coordination (PMCF)
Project coordination and contract management with clinical sites, study documentation preparation (protocols, eCRFs), monitoring and data analysis for post-market clinical evidence generation.
Digital biobank and annotation services
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.
Integrated AI development and validation platform
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.
Workshops and clinical immersion training
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.
Regulatory and technical advisory for medical AI
Consulting on regulatory best practices (including FDA and MDR-related considerations), clinical validation strategies, and project planning for AI-based medical technologies.
Usability engineering and evaluation 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.
Clinical study coordination (PMCF)
Project coordination and contract management with clinical sites, study documentation preparation (protocols, eCRFs), monitoring and data analysis for post-market clinical evidence generation.
Digital biobank and annotation services
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.
Integrated AI development and validation platform
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.
Workshops and clinical immersion training
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.
Regulatory and technical advisory for medical AI
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