We advise on the implementation, classification and certification of artificial intelligence and machine learning systems, in accordance with current and ensuing regulations – including the AI Act and ISO standards. We support both medtech entities and AI tool developers, helping to build regulatory strategies, prepare technical documentation, implement quality management systems (QMS), AI management (ISO 42001) and risk management (ISO 14971). We also offer comprehensive support in data acquisition, fulfilment of explainable AI obligations and the preparation of contracts for the creation, implementation and use of AI models. We combine technological, legal and business knowledge to support innovation in compliance with the law.
Qualification and classification of AI systems
Preparation of a regulatory strategy
Support in the preparation of technical documentation
Preparation, implement and audit of QMS systems
- ISO 42001 compliant AI management systems
- ISO 13485 compliant quality management systems
- ISO 14971 compliant risk management systems
Support with the implementation of explainable AI obligations
Training, validation and testing data capture
Support of obligations arising from the AI Act
Support re. AI medical devices
- preparation of a clinical assessment / performance evaluation for AI / ML devices
- medical data capture for training AI / ML algorithms
- support in meeting regulatory requirements for further training of AI / ML after conformity assessment
AI contracts
- AI tool development and implementation agreements
- data labelling agreements
- agreements on IP rights to trained AI models
- agreements on the use of the trained AI models and training data in other projects