FDA Software Validation for SW

[CADShark]

Has anyone had to make sure that SW was a "FDA Approved" software package. The FDA regulates software used in or for the manufacturing of medical devices. Such as any CAD program used to create drawings for said devices.
Our "IT" department has informed us that the program needs to be validated before we upgrade. Personnaly I think it's a load of bull. I've been using SWX since 98 and never had a problem with the FDA.

Thanks,
CADShark

 

[PDMAdmin]

We had that talk at one of my previous companies regarding Intralink, but we never actually got into validation mode. There are quite a few medical companies that use SolidWorks and PDMWorks; your VAR may be able to point you in the right direction.

 

[ctopher]

We do medical products and CAD software has never been brought up.

 

[CADShark]

I thought so, but I wanted to get the opinions of others.
I know that this regulation has been around for a few years so I'm not worrying about it to much.

Thanks a bunch!