Case Study:

Medical Device Company Engaged Safis to Validate an IVD (In-vitro Diagnostic) Assay


Our Client:

A medical device company engaged Safis to validate an IVD (in-vitro diagnostic) assay.


Safis was engaged to validate the changes to the assay protocol software and the operating system. Safis Solutions provided the following services:


  • Assisted with the creation of validation documentation
  • Ensured that all aspects of the electronic data collection were 21 CFR Part 11 compliant
  • Provided software testing plan
  • Wrote requirements documents
  • Developed test cases
  • Executed test cases
  • Authored test summary report
  • Assembled documentation used as part of the 510(k) submission