Hello everybody! I am working in the pharmaceutical industry and I am looking into the ISO 13485 standard. I know there are plenty of cases in Europe when the manufacturer of said pharmaceuticals starts all of the sudden producing medical devices. I was wondering if anyone might have a comparison matrix for those or some other type of resource that would outline their differences and similarities as I am only getting into researching the ISO 13485 and I am seeing lots of similarities between the two that make me confused of how the things are actually working as I am getting trouble on distinguishing the standart conformity and the regulatory compliance.
Thank you!
Thank you!