Data services and clinical validation for the development and approval of AI-based medical devices
Inventor AI (M3i GmbH)
MunichNew on Amplifa
About Inventor AI
Inventor AI is a Contract Research Organization (CRO) specialized in artificial intelligence, formed from the cooperation of M3i GmbH (Munich) and INVENTOR Medical GmbH (Heidelberg). The company offers data services for the development, approval and post-market surveillance of data- and AI-driven medical devices. The service portfolio includes Clinical Workflow Analysis, Clinical Use Case Analysis, the connection of clinical data centers via framework agreements, the procurement of clinical raw data, the creation of annotation guidelines, gold-standard annotations by clinical experts, data quality management as well as validation studies for clinical performance testing. The team has seven years of experience with AI projects in medical technology; more than half of the employees are physicians, complemented by medical informatics, business and electrical engineering experts. Through a network of over 400 clinical experts and 35 framework agreements with clinics in Europe across 15 medical specialties, Inventor AI has access to clinical real-world data. Project partners include the University Hospital Augsburg, Bayern-Innovativ, the KLS Martin Group, the University Hospital Heidelberg and the Brainlab AG.
- Site
- München
- Processes
- Clinical Workflow Analysis, Clinical Use Case Analysis, Integrating Clinical Data Centers, Acquisition of Clinical Raw Data, Creating Annotation Guidelines, Annotating Clinical Data, Data Quality Management, Validation & Approval (Clinical Performance Testing)
- Materials
- Clinical Workflow Analysis, Clinical Use Case Analysis, Integration Clinical Data Centers, Gold-Standard Annotation, Validation & Approval, Medical AI Consulting
- Certificates
- Certifications
- Industries
- Medical technology, Medical AI / AI-based medical devices
- 01
Clinical Workflow Analysis
- 02
Clinical Use Case Analysis
- 03
Integration of clinical data centers
- 04
Procurement of clinical raw data
- 05
Creation of annotation guidelines
- 06
Gold-standard annotation of clinical data
- 07
Data quality management
- 08
Validation and approval (Clinical Performance Testing)
Services and Processes
Clinical Workflow Analysis
Expert analysis of the clinical workflow to identify weaknesses and optimize the integration of AI medical devices.
Clinical Use Case Analysis
Examination and simulation of planned clinical use cases to optimize the standard of care.
Integration Clinical Data Centers
Enabling data access through framework agreements with clinics.
Gold-Standard Annotation
Standardized annotation of clinical training data by clinical experts.
Validation & Approval
Clinical performance testing to ensure regulatory approval and clinical evidence.
Medical AI Consulting
Consulting on regulatory and clinical requirements for AI-based medical devices.
Locations
Munich
DELocation (c/o M3i GmbH)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Clinical Workflow AnalysisEngineering | – | – | – | – | – |
| Clinical Use Case AnalysisEngineering | – | – | – | – | – |
| Integrating Clinical Data CentersTesting | – | – | – | – | – |
| Acquisition of Clinical Raw DataTesting | – | – | – | – | – |
| Creating Annotation GuidelinesTesting | – | – | – | – | – |
| Annotating Clinical DataTesting | – | – | – | – | – |
| Data Quality ManagementTesting | – | – | – | – | – |
| Validation & Approval (Clinical Performance Testing)Testing | – | – | – | – | – |
| 3D printing of individual implants (ADDIFEM project)Additive | – | – | – | – | – |
Additional services
Reference customers
Quality and Data Quality
Data quality is ensured through controlled processes in data quality management as well as gold-standard annotations by clinical experts. Validation studies and clinical performance testing provide the regulatory evidence for approvals.
| Evidence | Munich |
|---|---|
| Certifications |
History
Founded as a strategic cooperation between M3i GmbH (Munich) and INVENTOR Medical GmbH (Heidelberg) with a focus on Medical AI
The team has 7 years of experience with AI projects in medical technology; over 50 % of the team are physicians