B
BreeJeong
Hi there!
I'm getting a lot of help from here. Thank you, everybody!
I am not good at English. so please understand my English mistake
I have worked as a medical device RA only two years.
CE TCF of an orthopaedic implant (Class IIb) have been auditing since June 2016 by a notified body. It's not finishing yet. Last months, I received 2nd round of comments from my NB.
They said it is not clear that we have a PMCF study plan, and suggested clinical trial plan should be needed.
I prepared and summited a PMCF plan and a PMS procedure. so I have confused.
1) Are PMCF plan and PMCF study plan different?
2) If not the same, what are the differences? PMCF study plan is same to clinical investigation(clinical trial) plan?
I look forward to somebody's answer.
thank you for reading my questions
I'm getting a lot of help from here. Thank you, everybody!
I am not good at English. so please understand my English mistake
I have worked as a medical device RA only two years.
CE TCF of an orthopaedic implant (Class IIb) have been auditing since June 2016 by a notified body. It's not finishing yet. Last months, I received 2nd round of comments from my NB.
They said it is not clear that we have a PMCF study plan, and suggested clinical trial plan should be needed.
I prepared and summited a PMCF plan and a PMS procedure. so I have confused.
1) Are PMCF plan and PMCF study plan different?
2) If not the same, what are the differences? PMCF study plan is same to clinical investigation(clinical trial) plan?
I look forward to somebody's answer.
thank you for reading my questions