Hi - I've always worked in organisations who follow the design and development process for packaging and labelling as well as the medical device itself, by which I mean they would have design requirements defined, design reviews and V&V activities completed, so a full set of records. While the FDA 21 CFR 820 does specifically call for aspects of their Design Controls to be applied to packaging and labelling, it is less clear in ISO13485.
I just wondered what other have experienced? Have you managed to get ISO 13485 accreditation without applying section 7.3 to packaging and labelling?
I just wondered what other have experienced? Have you managed to get ISO 13485 accreditation without applying section 7.3 to packaging and labelling?