Generative AI: Practical innovation between efficiency and responsibility

Regulatory burden in medical technology is steadily increasing. MDR, FDA requirements and the forthcoming EU AI Act prolong development cycles and push costs upward At the same time, qualified specialists—particularly in Regulatory Affairs and Quality Assurance—are scarce.

Generative AI offers concrete solutions: it produces MDR-compliant submission documents in minutes instead of weeks, designs patient-specific implants via generative design, and, through semantic search, grants direct access to every development artefact. A key benefit lies in automatically capturing implicit expert knowledge—thoughts, considerations and decisions from design reviews flow seamlessly into formal documentation and simplify handling of field feedback.Complete data control is essential.

Specialised AI agents with med-tech expertise replace a patchwork of isolated tools with a central platform. All development and product data remain within the organisation’s own infrastructure; end-to-end encryption and detailed audit trails safeguard regulatory compliance. At the same time, the workload for approval documentation drops markedly.

The presentation uses practical examples to illustrate how generative AI accelerates development, reduces submission effort and preserves hidden expert knowledge for the entire product lifecycle—without compromising security or data sovereignty.