H
Hello -
Does anyone have experience here with meeting Design Control requirements (820.30) on existing products?
My company is getting a Blood Donor Screening test licensed, and the test was developed years ago for a different purpose, so no formal design control was documented.
I'm trying to work backwards from finished product, and it gets confusing.
I'll continue searching attachments and other threads, but I thought I'd ask if anyone has any tips/experience/examples to share.
Thank you!
H_H
Does anyone have experience here with meeting Design Control requirements (820.30) on existing products?
My company is getting a Blood Donor Screening test licensed, and the test was developed years ago for a different purpose, so no formal design control was documented.
I'm trying to work backwards from finished product, and it gets confusing.
I'll continue searching attachments and other threads, but I thought I'd ask if anyone has any tips/experience/examples to share.
Thank you!
H_H