invitro_spain
Involved In Discussions
Hi Folks,
I need help for this easy or not so easy question. During the premarket submission for a device Class II-Moderate risk, you have to include a summary of your bench studies and raw data (for example, spreadsheets with the data from your studies).
In this case, Should these spreadsheets comply with the 21 CFR Part 11?
Could you advise me about the most suitable way to comply with this regulation?
Thank you in advance
I need help for this easy or not so easy question. During the premarket submission for a device Class II-Moderate risk, you have to include a summary of your bench studies and raw data (for example, spreadsheets with the data from your studies).
In this case, Should these spreadsheets comply with the 21 CFR Part 11?
Could you advise me about the most suitable way to comply with this regulation?
Thank you in advance