Validation
Validation is the documented evidence that a process, system, or method reliably and reproducibly delivers the intended results. In the context of the medical device industry, this includes process validation according to ISO 13485, validation of software (including CAT tools and translation management systems), and validation of individual translation outputs through defined review and approval procedures. Validation differs from verification in that it demonstrates suitability for the intended use.
In the IFU translation process, both the translation process itself and each individual translation must be validated. This is a regulatory requirement of the quality management system and is reviewed by Notified Bodies during audits.
Frequently Asked Questions
How is the quality of IFU translations validated?+
Validation of IFU translations typically involves a multi-stage review process: specialist translation by qualified translators, independent review by a second specialist translator (four-eyes principle), terminological consistency check, formal QA checks (numbers, units, formatting), and final approval by the responsible person. This process must be documented and defined within the QMS.