J
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.
Jerome
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.
Jerome