For medical device manufactures changing equipment can be a grueling task. Obtaining new test equipment to combine processes and eliminate errors is exciting. However, the implementation of the new equipment quickly removes the excitement. The new tester must be verified and validated. In Verification and Validation Part 1, the steps involved for verifying an electrical safety tester were discussed. In this application note, Part 2, we discuss the validation process.

Part 2: Validation

The key portion of the validation process is the process itself. All too often manufactures try to validate the test equipment without a process in place. It is absolutely necessary to have the process nailed down before the validation can occur. Validation is a series of tests to ensure the tester does what it is intended to do. Without knowing what the tester is intended to do, it is impossible to verify it is doing it properly.