Hi, I'm new to the forum and new to dealing with FDA issues. My company is a manufacturer of wheelchairs and my question is how to handle the servicing under FDA guidelines.

Currently we offer our dealers a discount on the chairs and this is suppossed to imply that they will handle the servicing of our chairs. First of all, there is no written contract between us and the dealers. Secondly, if there techs perform the maintenance, repairs, etc. how should we handle service records? Basically, we don't have any record of service performed on the chairs. We only have records of calls that come in regarding warranty parts.

I hope my questions make sense and I appreciate any help that you can give me as I'm still muddling through trying to understand everything. Maybe I'm trying to make it harder than it really is, but it seems that we are lacking a lot in satisfying FDA in this area.

:bonk:

mfryar,

Welcome to the cove.

We may need a little more info from you.... what is FDA?

Food and Drug Administration.

I went out to www.fda.gov, I would contact the FDA and ask them about service for your type of product. (1-888-463-6332)

See if the FDA has some kind of Quality Management System Guidlines. That will help on what you may need to have in place!

Concern: that you have no agreement with your dealers on who is responsible for service, training, etc. Lets say they fix something and do not record it, your product is under warranty or fails in some way and soemone is hurt. No records, they are coming after you for damages. I think that you should consider some agreement on service, record appropriate information about the repair and keep records for appropriate amount of time. (IE see your attorney.)

Call the FDA and ask them about service records, maintenance etc for type of product and then speak with your attoney!

I am sure that they have some kid of standard to help you out.

I did a quick check, but I am not as familiar with FDA requirements to find the appropriate item.

Good luck!

Happy Holiday's

We do have the GMP 820 which is for Quality System Regulation. I agree about the contract with our dealers. I think we're missing that as well as having all service reports documented and sent to us.

I think I'm on the right track and I'll keep plowing along.

Thanks and Happy Holidays to you as well.