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Hegetor Labs specialises in the architectural design, technical development, clinical evaluation, and adoption of artificial intelligence as a medical device (AIaMD)
What is an AIaMD? Simply put, an AIaMD is an AI algorithm or software that performs a medical intended purpose such as the diagnosis, prevention, monitoring, treatment, mitigation, or prediction of a disease or condition.
Services
AIaMD Architectural Design
Design of AI and machine learning architectures for healthcare applications, including clinical prediction, classification, segmentation, denoising, automated speech recognition and generative AI.
AI & Machine Learning Development
Technical development, training, optimisation and evaluation of AI and machine learning models using clinical, biomedical and multimodal datasets.
Prospective Clinical Evaluation
Design and delivery support for prospective clinical evaluations of AI and machine learning technologies in real-world healthcare environments.
Evidence Generation Strategy
Development of comprehensive clinical evidence strategies to support the research, development, regulatory assessment and adoption of AI and machine learning models. We identify evidence requirements, systematical search, find and evaluate existing clinical and scientific literature, identify evidence gaps, design appropriate analytical and clinical studies,a dn support with the identification of grant opportunities.
Medical Device Regulatory Affairs
Specialist regulatory support for AIaMD and Software as a Medical Device, with particular emphasis on UK medical device requirements. We support intended-purpose definition, device qualification and classification, clinical evaluation planning, technical documentation and regulatory evidence generation.
Scientific & Technical Consultancy
Independent scientific, technical and strategic consultancy across artificial intelligence, machine learning and healthcare innovation. We advise academic institutions, healthcare organisations, medical technology companies and industry partners on AI feasibility, research design, algorithm development, clinical evaluation, regulatory strategy and implementation.
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