K
Hi Guys
I am currently working through my company's Technical File for a class II b medical device that we design and manufacture on site. We have had a CE mark on this product since 1995.
I am currently going through Technical File, 'tidying it up' and fixing some errors that were flagged as part of our audit's observations.
I have stumbled upon our 'block diagram' which is the most amazing mixture of different cliparts, over-sized arrows and random rectangles - it is so bad I'm actually quite amused (I wish I could post it for you to see)
ANYWAY, the point of my post - obviously we have received our CE mark despite this glorious picture for the past 15 years and it therefore it isn't an issue, but an outside customer has requested to see it and I would prefer it was redone before it was sent out (purely from a professional point of view) - obviously if I redesign it, I want it to be professional looking but also it has to have everything it is meant to have in it - Does anyone know what the requirements for the Block Diagram are? - does it need to have pictures/diagrams etc?
Thanks
I am currently working through my company's Technical File for a class II b medical device that we design and manufacture on site. We have had a CE mark on this product since 1995.
I am currently going through Technical File, 'tidying it up' and fixing some errors that were flagged as part of our audit's observations.
I have stumbled upon our 'block diagram' which is the most amazing mixture of different cliparts, over-sized arrows and random rectangles - it is so bad I'm actually quite amused (I wish I could post it for you to see)

ANYWAY, the point of my post - obviously we have received our CE mark despite this glorious picture for the past 15 years and it therefore it isn't an issue, but an outside customer has requested to see it and I would prefer it was redone before it was sent out (purely from a professional point of view) - obviously if I redesign it, I want it to be professional looking but also it has to have everything it is meant to have in it - Does anyone know what the requirements for the Block Diagram are? - does it need to have pictures/diagrams etc?
Thanks