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We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?
Our product is a class III single-use sterile device. We don't have any customer property and therefore Customer property, Installation, and Service have been excluded (not applicable). Does customer complaint/ feedback consider as Customer property?
I just start to work on document and record control. I cannot find "Medical Device File" in the tool kit. Could you provide me some guidelines/examples?
I'm looking for information on expired calibration of infusion/drivers. If an infusion/driver had a service/calibration sticker stating should not be used after April 2019 and was being used in an intensive care unit to keep a person alive would this breach the regs or SOP
I would like to know what are the similarities and differences between the two standards. I have experience with ISO 9001 and I have to implement ISO 13485. Could I rely to ISO 9001 or I need to get acquainted with this standard in detail?
Does your toolkit support requirements of ISO13485 in the scope of MDSAP?