AI as a Medical Device (AIaMD) & Machine Learning
The rapid advancement of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare has led to evolving global regulatory frameworks. From the EU AI Act to MHRA’s Change Programme and FDA’s ML SaMD framework — compliance is now more complex than ever.
At Apotech, we help you meet these requirements while accelerating your path to market. Our regulatory team understands the nuances of AI in healthcare and can support your device through every stage of development and approval.
Trusted by top-tier teams worldwide
Our AIaMD Support Includes
- Pre-market regulatory strategy development
Including Intended Use definition, Risk Classification, and Technical File readiness. - QMS implementation for AIaMD
Systems aligned with ISO 13485, ISO 14971, ISO/IEC 42001, IEC 62304, IEC 82304-1, and Good Machine Learning Practice (GMLP) from global regulators. - Regulatory submissions and approvals
Technical documentation and regulatory pathway planning aligned with MDR, IVDR, and FDA frameworks. - Clinical Evaluation
Preparation of CEPs, CERs, literature reviews, and PMCF strategies specific to AI-driven functionality. - Post-market surveillance and vigilance
Real-world performance monitoring, risk mitigation, and reporting compliance.
- Training and education
Specialist programmes designed to equip teams with a working understanding of AIaMD compliance.
Featured case studies
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…