M
melissa87
Hi,
I have the following question regarding classII medical device. I recently joined this company earlier this year.
My company is a startup and did not know anything about QMS. The engineers designed and developed the device in the period 2005 to 2011 and with a help of FDA consultant wrote 510K and submit it to FDA. FDA approved the device in 2012.
They also got 5 prototypes built too. FDA came to investigate us earlier this year but we did not sell any and never went to production stage so FDA said that since you are in verification and validation stage so there is nothing to investigate. We will come later.
Now my boss wants to go to production stage but design control does not exist. The 510k that engineers wrote do include
1. verification and validation documents
2. Test Results
3. Design Input
4. Design outputs
etc.
But there was no Design Control SOP or any other SOP exsisted at that time. Now my boss wants to go to prodcution stage asap.
I have all the documentation regarding production stage like DMR, FMEA , Drawings, CAPA SOP, Supplier Control SOP, Document control SOP, etc.
But the Design Control needs to be done and formally put in place and evolved. My question is
1. If I do Design Control now, how would FDA will view it at the time of the next Audit because it never exsisted when it should exsisted and I might not be done with it soon and my boss wants to go to production. I might get all done during production.
2. Can I initiate Design Control work using a CAPA( Corrective Action)?
Please comment!
Melissa
I have the following question regarding classII medical device. I recently joined this company earlier this year.
My company is a startup and did not know anything about QMS. The engineers designed and developed the device in the period 2005 to 2011 and with a help of FDA consultant wrote 510K and submit it to FDA. FDA approved the device in 2012.
They also got 5 prototypes built too. FDA came to investigate us earlier this year but we did not sell any and never went to production stage so FDA said that since you are in verification and validation stage so there is nothing to investigate. We will come later.
Now my boss wants to go to production stage but design control does not exist. The 510k that engineers wrote do include
1. verification and validation documents
2. Test Results
3. Design Input
4. Design outputs
etc.
But there was no Design Control SOP or any other SOP exsisted at that time. Now my boss wants to go to prodcution stage asap.
I have all the documentation regarding production stage like DMR, FMEA , Drawings, CAPA SOP, Supplier Control SOP, Document control SOP, etc.
But the Design Control needs to be done and formally put in place and evolved. My question is
1. If I do Design Control now, how would FDA will view it at the time of the next Audit because it never exsisted when it should exsisted and I might not be done with it soon and my boss wants to go to production. I might get all done during production.
2. Can I initiate Design Control work using a CAPA( Corrective Action)?
Please comment!
Melissa