D
DangerousDave
Hi All
I have recently taken over as Reg Affairs person in a small electronics company where my predecessor has done no work on updating technical files for several years, and now I am in a position to get them up to date pretty pronto (especially as 2007 MDD comes into effect in March). We manufacture class IIa medical devices.
My predecessor "claimed" that she was "allowed" to generate clinical evaluations for technical files as she had a medical degree, and someone like myself wouldn't as I do not have a medical degree (electronic engineering is my background). Is this the case?
I have seen several examples of how to do a clinical evaluation on a class II device on the forum, and in the same way many of these are, we have had most of our products on the market for many many years with no incidents, and our retrospective clinical evaluations would be based on this.
Any advice greatly appreciated.
Dave
I have recently taken over as Reg Affairs person in a small electronics company where my predecessor has done no work on updating technical files for several years, and now I am in a position to get them up to date pretty pronto (especially as 2007 MDD comes into effect in March). We manufacture class IIa medical devices.
My predecessor "claimed" that she was "allowed" to generate clinical evaluations for technical files as she had a medical degree, and someone like myself wouldn't as I do not have a medical degree (electronic engineering is my background). Is this the case?
I have seen several examples of how to do a clinical evaluation on a class II device on the forum, and in the same way many of these are, we have had most of our products on the market for many many years with no incidents, and our retrospective clinical evaluations would be based on this.
Any advice greatly appreciated.
Dave