MDR fixes - Resolutions to MDR's for out-of-contract customers

[doubtintom]

A client is curious about how other software medical device companies address providing resolutions to MDR's in older releases of software.

They currently have releases in the field going back to early 2000. When they discover an MDR they typically also discover that the mistake that led to the MDR was not committed in the most recent release but in one 2 years and 2 months ago. That presents a problem. They resolve the MDR in the next release of software free to all customers on a software support contract. For those not on contract, they tell them they will sell them the resolution but they must upgrade to the upcoming release to get it. It sounds funky but to date they haven't had customers complain.

What do other SW medical device companies do to resolve MDR type issues for older customers who may be affected? We're looking for practical experience.

Thanks!

 

[Al Rosen]

A client is curious about how other software medical device companies address providing resolutions to MDR's in older releases of software.

They currently have releases in the field going back to early 2000. When they discover an MDR they typically also discover that the mistake that led to the MDR was not committed in the most recent release but in one 2 years and 2 months ago. That presents a problem. They resolve the MDR in the next release of software free to all customers on a software support contract. For those not on contract, they tell them they will sell them the resolution but they must upgrade to the upcoming release to get it. It sounds funky but to date they haven't had customers complain.

What do other SW medical device companies do to resolve MDR type issues for older customers who may be affected? We're looking for practical experience.

Thanks!

If it is an MDR, they must fix the issue whether the customer is on contract or not. Also look at 21cfr806, Reports of Corrections and Removals.

 

[Kevin Mader]

Tom,

Als correct. Keep in mind these two things:

- FDA will assume you implied that there was risk to the public by the filing of an MDR
- FDA will consider the correction made to those customers on contract a field correction (remedial action).

Due diligence was not fully performed.

Regards,

Kevin