Software Medical Device - 7.3.8 - Design and Development Transfer

[lylam]

Hello Everyone,
Can you share with me your experience in meeting the requirements for section 7.3.8 - Design and Development Transfer? I believe we can simply mix section 7.3.6, 7.3.7, and 7.3.8 into a process to "Test and Release" the device (software package) but wondering if there is any better way to implement it?

Thanks,
Ly

 

[BhupinderSinghPawa]

For Medical Device containing Software, we structured the following SOP's;
Software Development Process,
Software Maintenance Process,
Software Configuration Management Process,
Software Problem Resolution Process.
; that in association with product or system level SOP's;
Product Design and Development,
Design Transfer / Device Master Record, (software is one of the elements for transfer)
Risk Management;
addressed the requirements of 62304 in conjunction with 13485.

The software release was put as part of software configuration management process - addresses 5.8 of 62304.

For Software only as a Medical Device, you can have a Software Release process that includes the DMR / Design Transfer. IMO, the Software development process should address the unit - integration - system testing, as applicable.

 

[yodon]

Yeah, that's a little weird for software.

But I think there is an application. At some point, you have to deploy the software - whether flashing into memory, providing via download, or providing via a cloud service. Getting the software (executables) from development and deployed is pretty much what we address. We have measures to ensure the correct software is deployed (CM) and that the software is deployed correctly (checksums, typically).

 

[lylam]

Many thanks to BhupinderSinghPawa and Yodon for your answers. I actually cover the mentioned section in SOP 730. Concerning deployment of the software as Yodon mentioned, I believe we should better address it in SOP 750 to cover section 7.5.3

 

[Chromehounds]

Good to know. Thanks.