K
Hello!
My backstory is a that we're a very small medical device manufacturer that manufactures (what will be) Class I and II devices (very low-risk), and I have no experience in the Quality Field at all. We haven't had a documented quality system and the required FDA files (DMRs, DHRs, and DHFs).
We're putting those together and it wouldn't be possible without this forum. So much of the Quality Industry is implicit knowledge and experience-based and this forum really helps! So, thank you!!!
I have two questions-
The FDA has us on its radar and we have a warning letter. We are going to be applying for 510(k)s and DeNovos (or PreDeNovos) in the 4th quarter this year.
Some of our products have been on the market for a long time.
We don't have everything that went into the design back then and we do have a number of changes that have occurred since that first product(s) went on sale.
1. The retrospective DHF - does anyone have any advice on where to begin?
Should we begin with the current iteration of the device (fresh start) or should we attempt to piece it together to the best of our ability?
In the former's case - should the primary design input be the older design? Do we still need a planning stage and documentation?
2. We're a small (tiny) company and changes are very rapid in terms of design and process. Once we have a DHF in place (and the DMR), and we apply for and register the product with the FDA, how do we incorporate these changes (assuming we do the documented input, review, output process) before we have to file changes before the FDA?
Should we attempt having more static products and processes after a 510(k)?
For example, we make minor modifications like adding digital output, or an extra input port; or assembly procedure may change based on who's doing what and what they learn on the job.
I understand that all the little changes eventually add up, but it's, sort of like, company culture (we're 3 people strong here) to change things ever so often.
I hope the questions make sense. Any help will be much appreciated!
Regards,
Krthna.
My backstory is a that we're a very small medical device manufacturer that manufactures (what will be) Class I and II devices (very low-risk), and I have no experience in the Quality Field at all. We haven't had a documented quality system and the required FDA files (DMRs, DHRs, and DHFs).
We're putting those together and it wouldn't be possible without this forum. So much of the Quality Industry is implicit knowledge and experience-based and this forum really helps! So, thank you!!!
I have two questions-
The FDA has us on its radar and we have a warning letter. We are going to be applying for 510(k)s and DeNovos (or PreDeNovos) in the 4th quarter this year.
Some of our products have been on the market for a long time.
We don't have everything that went into the design back then and we do have a number of changes that have occurred since that first product(s) went on sale.
1. The retrospective DHF - does anyone have any advice on where to begin?
Should we begin with the current iteration of the device (fresh start) or should we attempt to piece it together to the best of our ability?
In the former's case - should the primary design input be the older design? Do we still need a planning stage and documentation?
2. We're a small (tiny) company and changes are very rapid in terms of design and process. Once we have a DHF in place (and the DMR), and we apply for and register the product with the FDA, how do we incorporate these changes (assuming we do the documented input, review, output process) before we have to file changes before the FDA?
Should we attempt having more static products and processes after a 510(k)?
For example, we make minor modifications like adding digital output, or an extra input port; or assembly procedure may change based on who's doing what and what they learn on the job.
I understand that all the little changes eventually add up, but it's, sort of like, company culture (we're 3 people strong here) to change things ever so often.
I hope the questions make sense. Any help will be much appreciated!
Regards,
Krthna.