Regina Preysing provides digitalization of regulatory compliance and documentation fit for MDR/IVDR/FDA & AI

As an experienced compliance expert and digitalization specialist, Regina supports medical device manufacturers in future-proofing their regulatory documentation. Her focus: transforming existing documents into modularized knowledge modules – as the basis for efficient compliance management, automation, and AI applications.

Her offer includes:

• Structuring technical documentation in accordance with MDR/IVDR/FDA requirements into reusable, linked information units
• Transferring documentation from paper/Word/Excel/PDF to PLM/QMS systems (e.g., MatrixALM, Atlassian) for lively, well-maintained documentation
• Identification and implementation of use cases for digital automation and AI in PLM processes

With hybrid expertise in medical device regulation (10+ years), IT architecture (20+ years at IBM), and practical experience in implementing documentation software (e.g., as product owner at Matrix Requirements), Regina builds the bridge between regulatory requirements and technical feasibility.

Together with clients, she turns compliance documentation into an enabler for efficiency and innovation.

Regina also provides support with quality management, product development, and CE/FDA applications