Generative AI: Practical innovation between efficiency and responsibility
Regulatory requirements are increasing. Generative AI accelerates development, automates approval documents, and secures expert knowledge—with full data control. In Martin Egloff's presentation, you will learn how medtech manufacturers can efficiently optimize their lifecycle processes.
The regulatory burden in medical technology is constantly increasing. MDR, FDA requirements, and the upcoming EUAI Act are extending development cycles and driving up costs. At the same time, there is a shortage of qualified specialists, especially in regulatory affairs and quality assurance.
Generative AI provides concrete approaches: it creates MDR-compliant approval documents in minutes instead of weeks, designs patient-specific implants using generative design, and enables direct access to all development artifacts through semantic search. Particular added value is created by the automatic capture of implicit expert knowledge—thoughts, considerations, and decisions from design reviews flow seamlessly into the official documentation and facilitate the processing of feedback from the field.
Full data control is a key requirement. Specialized AI agents with medical technology expertise replace a proliferation of tools with a central platform. All development and product data remains within your own infrastructure; end-to-end encryption and detailed audit trails ensure regulatory compliance. At the same time, the effort required for approval documentation is significantly reduced.Using practical examples, the presentation shows how generative AI accelerates development processes, reduces approval costs, and makes hidden expert knowledge usable in the long term—without compromising security or data sovereignty.
Note: This presentation was given in German.
Speaker:
Martin Egloff, Head of Business Area MedTech/Healthcare
