Design History File Maintenance - Who is responsible for the Design History File

A

allendavid

#1
We are one design house for medica project. Sometimes we got the project from some customers, they just ask us provide revised schematic and layout, and we have agreement that we are not responsible for DHF maintainance, they can do. But we have process for DHF, should we do DHF or leave it to customers?
 
Elsmar Forum Sponsor
#2
Re: Design History File

We are one design house for medica project. Sometimes we got the project from some customers, they just ask us provide revised schematic and layout, and we have agreement that we are not responsible for DHF maintainance, they can do. But we have process for DHF, should we do DHF or leave it to customers?
Design is your service and customer's responsibility ~~~
 
M

MIREGMGR

#4
The customer is the buyer. They should issue a purchase order to you, or have a purchase agreement in place, that defines what they are buying from you. They are responsible for maintaining the DHF. They might however contract with you, via the P.O., for you to create their DHF up to the point of your delivery, and hand it over to them.

If they don't address this question, you might want to discuss it with them, in the spirit of making yourself more valuable to them by demonstrating your expertise in their field and your willingness to look out for their best interests.
 
S

Sybarite

#5
This question should not be directed to an online forum, but should be reviewed in whatever contract you have in place with your customer, or directly with your customer, as another poster has suggested. We may be able to give you our opinion, but that does not relieve you of legal responsibility if it is indeed spelled out in your contract.
 
M

MIREGMGR

#6
...that does not relieve you of legal responsibility if it is indeed spelled out in your contract.
Maybe "legal responsibility" here needs a comment.

There's legal-under-the-FD&C-Act responsibility, and legal-under-contract-law responsibility.

It isn't legally possible for a USFDA-regulatorily-responsible medical device Manufacturer to shift the former responsibility to a contract device maker/design house. The Manufacturer is fully and solely responsible, in this case for the DHF, no matter what the terms of a contract they arrange to have someone help them do the work.

Of course, if the Manufacturer and a contract device design house enter into a legal agreement (a contract) to do design work and document that work for the DHF, then there is a legal responsibility for that work under contract law. The FDA, though, won't care about that contract. They'll only look to the Manufacturer.
 
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