IVDR Case Study

New European Union (EU) regulations require In Vitro Diagnostic (IVD) manufacturers to proactively collect, evaluate, and document post-market performance data. This is to maintain quality and safety throughout the product life cycle.

The process requires experts to read massive volumes of medical literature to find the passages relevant to their products to stay in compliance.

A large diagnostics company approached Sorcero regarding a solution to help them review and process the exponentially increasing amount of clinical literature.

Case Study: Preparing for IVDR

Industry challenges:

• New E.U. IVD regulations
• 30-35 hours a week to monitor literature per M.D. or Ph.D.
• Manually review 25-50% of the relevant materials

Solution:

• 1-2.5 hours a week to monitor literature per M.D. or Ph.D. (82-90% less time spent)
• Review 100% of the relevant materials
• Increase monitored products from 6 to 20

Download the IVDR Diagnostics Case Study to see the real-world results