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nick lekanides
i am currently updating my company to the MDD and ISO 13485, and am currently stuck on a few things regarding the labeling and packaging of my products, especially regarding the Instructions for Use:
1. exactly what products do the Instructions for Use (IFUs) have to be included with? eg. do they only have to be packaged with a complete device? or, do they have to be included with all main components? or, do the IFUs have to be packaged with every individual component and replacement part?
2. what information regarding my company must be included on the IFU? on the labels? eg. the company logo, the manufacturers contacts and address, parts descriptions, expiration dates (if applicable), etc.
1. exactly what products do the Instructions for Use (IFUs) have to be included with? eg. do they only have to be packaged with a complete device? or, do they have to be included with all main components? or, do the IFUs have to be packaged with every individual component and replacement part?
2. what information regarding my company must be included on the IFU? on the labels? eg. the company logo, the manufacturers contacts and address, parts descriptions, expiration dates (if applicable), etc.