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DIGICAP explained - Data is flowing from a document into a structure
Medical Device Regulation

DIGICAP explained for RA and QM teams

A new Horizon Europe project wants to replace PDFs and spreadsheets in MDR and IVDR conformity assessment with structured, machine-readable data. Here is what DIGICAP is, what it is not, and what you can sensibly do before 2029.

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Michael Kania

Sep 8, 2026

IVDR - Repetitions and Constant Déjà Vus...
In Vitro Diagnostic Regulation

IVDR - Repetitions and Constant Déjà Vus...

This post explores the challenges of managing redundant information in technical documentation for the In Vitro Diagnostic Regulation (IVDR) It highlights the potential pitfalls, document management issues, and the need for a more efficient approach. The post introduces meddevo as a solution to revolutionize and streamline product information management, ultimately enhancing regulatory compliance.

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Marie Rogowski

Sep 24, 2024