Interesting Discussion Chapter 7.5 of ISO 13485 for manufacturers of mobile medical applications

[Roland chung]

Hi everyone,
I believe that some fellows in the forum are from manufacturers of mobile medical applications. Since the apps are sold in Google or Apple store, there is no traditional production process, does the chapter 7.5 (production) of ISO 13485 apply?
Thank you!
Roland

 

[William55401]

13485 Product Realization absolutely applies. I respect that you are not a manufacturer a tangible product. However, how does your org ensure the right file, fully verified and approved, is uploaded to the app store(s)? You are likely relying on a cloud partner and have internal tools to manage this workflow. Are your processes defined? From prior experience, I can tell you that errors can occur in this virtual production process.

 

[Junn1992]

yes absolutely. the "manufacturing" are the PCs used to code the medical device application

 

[mihzago]

Production controls generally apply to stand-alone software, but many if not all activities are typically performed during the Design and Development and completed during the Design Transfer.
In my QMS, I don't have separate procedures for production controls. Instead, in the quality manual, for the items in clause 7.5 I explain that these activities are covered in design and development.

 

[somashekar]

Hi everyone,
I believe that some fellows in the forum are from manufacturers of mobile medical applications. Since the apps are sold in Google or Apple store, there is no traditional production process, does the chapter 7.5 (production) of ISO 13485 apply?
Thank you!
Roland

It applies.
7.5 is Production and service provision. Here, now please get back to clause 3.15 and understand the definition of Product.