Fellow members,
We are undergoing a stage II MDSAP audit for Canada, US and Australia for our class II medical device. The auditor asked for our SOP on how we seek regulatory clearance in these three countries, and how we keep our licenses active.
Given the apparent generic nature of this information, do you have any templates that I could use? Or would the SOP involve outlining the regulatory steps needed to achieve clearance, such as the 510(k) decision flowchart etc?
Any guidance that you can provide on this is greatly appreciated. Thank you for your time.
We are undergoing a stage II MDSAP audit for Canada, US and Australia for our class II medical device. The auditor asked for our SOP on how we seek regulatory clearance in these three countries, and how we keep our licenses active.
Given the apparent generic nature of this information, do you have any templates that I could use? Or would the SOP involve outlining the regulatory steps needed to achieve clearance, such as the 510(k) decision flowchart etc?
Any guidance that you can provide on this is greatly appreciated. Thank you for your time.