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
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