Configurable/Custom made or accessories?

EliJones

Registered
Dear Elsmar users,

I am working on Configurable medical devices.

These devices are postural support chairs which are assessed by occupational therapists, this means the base chair is build up to order with a wide variety of add ons.

Im looking for some advice on the best conformity assessment route for these.
Do we think that these devices could be considered "Custom made"?
Should each add on be considered a Medical Device in its own right as an accessory?
Or should the device be covered as one technical file with optional extras some how?

Any advice would be appreciated, I cant get my head round how to cover this type of product from a technical documentation perspective.

Thanks
 
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