Informal vs formal scope creep... managing non-medical devices through system processes

James

Involved In Discussions
#1
Hello fellow forum dwellers

My system serves class 1 devices that we make or modify. However, in some circumstances, we modify devices that aren't medical devices, mostly they are 'aids for daily living' instead. I've suggested in our documentation that to make things easier and clearer, we consider all of the manufacturing and modifying as being a medical device related, and apply system principles to it. We do not 'place on the market', we are a health institution operating under exemption.

The alternative to this is that we keep the 'formal' scope quite narrow and just applied to medical devices, but we 'informally' use our E-QMS platform for these devices. We clarify when we do that, that they are on the platform for the purposes of maintaining consistent and good working practices, but are not formally 'in scope' of our system.

I think that considering everything we make as a medical device and applying those high standards will be the most risk adverse approach for managing them, but I'm unsure of which route (formal vs informal) will serve my purposes best. Again, these are small volumes (maybe 40 per year) of custom-made, low risk devices.

Any thoughts appreciated!

James
 
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indubioush

Quite Involved in Discussions
#2
In my opinion, the best way to go about this is to keep both items in the system but different levels of controls. Define and document a way of identifying medical devices and items that are not medical devices. Then some of your quality system documents will state in the scope section that "this procedure is only applicable to medical devices." You will have other procedures that are applicable to both and the scope will not have the previous statement. Does that make sense?

For example, you will have a nonconforming procedure procedure that is applicable to medical devices only. Then you will have a design and development procedure that could have minimal requirements for non-medical products and full requirements for medical devices.
 

James

Involved In Discussions
#3
You will have other procedures that are applicable to both and the scope will not have the previous statement. Does that make sense?

For example, you will have a nonconforming procedure procedure that is applicable to medical devices only.
Thanks; yes, that might work. I think as a matter of good practice we might want everything to conform to the UK MD regs (if it's not a MD, it's something very similar anyway); but as you suggest, separating out NCs may help for data monitoring purposes if nothing else.
 
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