QAengineer13
Quite Involved in Discussions
Dear Cove members,
I need some guidance pertaining to product change and the decision as to when to submit and when to document LTF and update the QMS.
I am fully aware about the below guidance document :
1) When to submit a 510k - FDA
2) Guidance for the interpretation of significant change- HC
3) NB-MED: Reporting design change (EU)
The above mentioned guidance document helped me in streamlining the process for respective countries health authority requirements , the question I am seeking for an answer now :
1) If you can kindly share some doc's or process you use to handle design change decisions.
2)How can I further classify the design change to class specific.
Your input is highly appreciated!
Thank you
I need some guidance pertaining to product change and the decision as to when to submit and when to document LTF and update the QMS.
I am fully aware about the below guidance document :
1) When to submit a 510k - FDA
2) Guidance for the interpretation of significant change- HC
3) NB-MED: Reporting design change (EU)
The above mentioned guidance document helped me in streamlining the process for respective countries health authority requirements , the question I am seeking for an answer now :
1) If you can kindly share some doc's or process you use to handle design change decisions.
2)How can I further classify the design change to class specific.
Your input is highly appreciated!
Thank you