Greetings Covers,

I'm not sure if this is the right place to post this question, but I'll give it a try (if not, please move to correct thread).
I've been assigned to create some technical documentation for a product.
This product comes in various models (6 or 7) of which two models are class IIa (EU) medical devices (due to the inteded purpose and use).
Is it wise to split the technical documentation with regards to medical devices and other devices?
Im currently building the file that way but was thinking to make one file for the whole product "group".
I've made a part A (tech doc describing the product/group with summaries of part B) and a part B (production protocols/drawings and testing details).

The Medical Device Models still need to be offered to a notified body for CE-approval.

Since I'm new to this, the only one in our company doing this and starting from scratch, any input on whether I'm on the right track is highly appreciated.

:thanx:

Jerome

Greetings Covers,

I'm not sure if this is the right place to post this question, but I'll give it a try (if not, please move to correct thread).
I've been assigned to create some technical documentation for a product.
This product comes in various models (6 or 7) of which two models are class IIa (EU) medical devices (due to the inteded purpose and use).
Is it wise to split the technical documentation with regards to medical devices and other devices?
Im currently building the file that way but was thinking to make one file for the whole product "group".
I've made a part A (tech doc describing the product/group with summaries of part B) and a part B (production protocols/drawings and testing details).

The Medical Device Models still need to be offered to a notified body for CE-approval.

Since I'm new to this, the only one in our company doing this and starting from scratch, any input on whether I'm on the right track is highly appreciated.

:thanx:

JeromeI don't see the need to do this if there is no difference in the products and how you produce them. Are there additional steps or processes that are applied to the medical devices?

Thank you Al.
Yes, all the models are different from each other. And the medical devices are equipment to be used by profesionals, while the non-medical devices are bought by device builders (as OEM parts I believe)...
Knowing this (just now), I think I know what to do now and will splitt the bunch in MD's and OEM's with seperate tech files, since the requirements by authorities are different per group.

Best regards,
Jerome

Thank you Al.
Yes, all the models are different from each other. And the medical devices are equipment to be used by profesionals, while the non-medical devices are bought by device builders (as OEM parts I believe)...
Knowing this (just now), I think I know what to do now and will splitt the bunch in MD's and OEM's with seperate tech files, since the requirements by authorities are different per group.

Best regards,
JeromeYou are the one to know what will work best for you.