Overview

Due to the safety critical nature of the products B. Braun produces, stringent development and verification processes are required. Only after passing the verification tests is a product allowed to be sold. This demonstrates the importance of having a complete test procedure.

To ensure the tests were comprehensive, B. Braun called on Paragon to evaluate and review their procedure. Paragon’s previous experience in the design and verification of medical products proved beneficial. The tests were found to be fairly comprehensive. To complete the testing, only a single addition was needed.

Results

• B. Braun had an independent company (Paragon Innovations) verify their testing procedures.
• A comprehensive test procedure is currently being used to test the product in production.
• Documentation on the findings were provided to B. Braun.