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We will be NOT be designing or making medical devices. We will be molding plastic components that do not require sterilization. What should we exclude from our Procedures and/or Quality Manual?
I was wondering if you can help me with this question. This is regarding change controls specifically for changes to the quality system procedures such as SOPs and Work Instructions. How would these changes be initiated, reviewed and approved? I noticed there was not a change control form for this and I thought there would have been one in the Procedure for Document and Record Control.
1. Do you have in your 13485 & MDR package documents required by MDSAP? If no, where I can get them.
2. The same question about your 13485 & MDR package documents required by FDA?"
Looking at the first folder “00”, what is the difference between list of internal documents and list of type of records?