DEVigil
Involved In Discussions
Hello, fellow Covers!
I am at my wits' end. We are a small startup, and have a contract with a certain NB/CB for our ISO 13485 cert and CE marking of software medical devices. I have been trying since January to get surveillance audit dates for this year. Our audits are supposed to be in May, and as you can tell by the date of this post there isn't a whole lot of May left... and I still have no indication when we might be scheduled, despite numerous requests. They claim to have a (presumably internal) rule that audits can be +/- two months, but aside from that they have made no move to actually schedule us.
We also recently added a new product, for which we submitted the proper notification to the NB. This product, for which our 510(k) was successfully processed in under 30 days, needs its technical file reviewed before we can CE mark it and sell in the EU (which is where the customer base is). No word on when that will be taken up either - and Executive Management is steaming, because we have distributors lining up who won't be able to sell it until this is done, and we can't even give an estimate of when that might be because we can pry nothing out of the NB.
Our CEO is threatening to chew his way up the food chain at the CB/NB, and I am seriously contemplating lodging a formal complaint with the relevant Competent Authority. I'm worried there will be retributive backlash during subsequent audits, but at this point I'll take that if it means we actually get them.
I'd appreciate any and all advice on how best to deal with this situation. Also, I know the NBs are all slammed, but at this point advice on how to change NBs (i.e., timing) would also be welcome.
Thanks for hearing me out!
Debra
I am at my wits' end. We are a small startup, and have a contract with a certain NB/CB for our ISO 13485 cert and CE marking of software medical devices. I have been trying since January to get surveillance audit dates for this year. Our audits are supposed to be in May, and as you can tell by the date of this post there isn't a whole lot of May left... and I still have no indication when we might be scheduled, despite numerous requests. They claim to have a (presumably internal) rule that audits can be +/- two months, but aside from that they have made no move to actually schedule us.
We also recently added a new product, for which we submitted the proper notification to the NB. This product, for which our 510(k) was successfully processed in under 30 days, needs its technical file reviewed before we can CE mark it and sell in the EU (which is where the customer base is). No word on when that will be taken up either - and Executive Management is steaming, because we have distributors lining up who won't be able to sell it until this is done, and we can't even give an estimate of when that might be because we can pry nothing out of the NB.
Our CEO is threatening to chew his way up the food chain at the CB/NB, and I am seriously contemplating lodging a formal complaint with the relevant Competent Authority. I'm worried there will be retributive backlash during subsequent audits, but at this point I'll take that if it means we actually get them.
I'd appreciate any and all advice on how best to deal with this situation. Also, I know the NBs are all slammed, but at this point advice on how to change NBs (i.e., timing) would also be welcome.
Thanks for hearing me out!
Debra