Process Validations
The validation of processes is one of the most slogged on issue among medical device producers. Medical device producers frequently confuse especially the validation, verification and revalidation concepts.
Validation: The proof that the process, which was conducted with an equipment and specified parameters, has resolved the desired outcome each time.
Verification: The justification of the convenience of the process that is obtained by the periodic controls by the company or by another party while considering the effect of the process on the product reliance and performance.
Revalidation: The repetition of the product validation, if considered necessary, after the assessment conducted with the consideration of the effects of alterations that will be made for issues (i.e. machine, parameter) on process validation during the validated process.
EN ISO 13485: In accordance with the 7.5.6 issue of 2016 Standard, medical device producers should validate all processes in which the inconvenience of the product will be understandable only after the product is in use and in which the product convenience in one party is not confirmed by the process and post-process controls while considering the effects of applied process on the medical device that they have produced and the frequency of controls and competences that they have applied for their process.