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VigInfo AI

Area

Product

product

Cloud-Based AI Platform for Regulatory Compliance

Client

B2B
B2G

An AI platform for literature processing in accordance with the MDR

VigInfo s.r.o. develops a cloud-based AI platform for the automated processing of professional literature in the fields of vigilance, clinical trials, and post-market surveillance of medical devices. The solution replaces manual, costly, and duplicative processes with a unified system that identifies safety signals and clinical effects, classifies incidents, and generates outputs usable for audits and regulatory documentation. The platform integrates with external databases and QMS systems and is fully scalable.

Unique Selling Points:

  • A unified AI platform for comprehensive analysis of scientific literature in accordance with regulatory requirements.
  • No capacity limitations—maximum scalability and flexibility.
  • Full integration with external databases of technical literature and QMS systems.
  • Advanced AI automation delivers significant time and cost savings compared to manual work.
  • A unique technology architecture with no direct competitors on the market.

Incubation

Challenge 1/2025

Technology readiness

  1. Development
  2. Proof of concept
  3. Prototype
  4. First implementation
  5. Extensive implementation

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