Process Validation / Process Validations

One of the most challenging topics for medical device manufacturers, especially the concepts of Validation, Verification, and Revalidation, is often confused by many medical device manufacturers.

Validation: This is the proof that a process performed with equipment under specific parameters consistently achieves the desired result for the manufacturer.

Verification: This is the confirmation of the process’s compliance at determined intervals, considering its effects on product safety and performance, through controls performed or commissioned.

Revalidation: This is the evaluation process performed when changes are made to aspects of the validated process, such as machinery or parameters, considering how these changes may affect the process validation. If necessary, the process is revalidated after this evaluation.

In accordance with EN ISO 13485:2016 Standard, Clause 7.5.6, medical device manufacturers must validate all processes where the compliance of every product in a batch cannot be verified through processes and subsequent controls, and where non-conformities can only be detected after the product has entered use. They must validate these processes, taking into account their effects on the manufactured medical device, as well as the frequency and adequacy of the controls applied to the process.