How many hrs does it take to create a Technical File (TD)?

Vetty007

Starting to get Involved
#1
Hi,

unfortuantely I couldn't find an answer to the question, how long it will take to create a technical file from nearly zero? I know, that this can be quite different due to the huge range of medical devices, but I just want to have an idea, so that I can plan with the working hours of my employees. Of course it also depends, how fast they work in general. Also I want to compare this to an offer from a consultant and freelancer, which also give very different hours for the same task. My calculation is also different and thus I wonder, what could be realisitic hours to be planned for TD creation? In my calculation I ended up with about 600 - 800 hrs and I was shocked, ending up with that much hrs, despite a lot of tasks i expect to take approx. 1 day. The Consultant even nearly had 1500 hrs, the freelancer 1.200 hrs. Thus I am also afraid, that I possibly underrated the whole project. Thus I would be very happy, if you could share your taughts about the needed hrs for TD creation :)

And just a last question, could you recommend to buy templates and do they helped you to save a significant amount of time? I was interessted in the advisera templates, but according to the preview it would not save much time and seems to be more reminding not to forget special aspects, but not giving something like a full description. So I am hesitating, if this will help to save significant time while improving quality. Any experience with it or other recommendations for templates?

Thank you very much in advance!
 
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ECHO

Involved In Discussions
#2
Significant parts of the the technical file is a byproduct of the product development lifecycle. Are you including the product development time to this estimate? If so, one product I worked on took 12 months of 15 engineers to get a submission ready tech file. and that is with an existing product development pipeline.

I recommend breaking down the components of the technical file as far as possible and get individual quotes on those components.

And just a last question, could you recommend to buy templates and do they helped you to save a significant amount of time? I was interessted in the advisera templates, but according to the preview it would not save much time and seems to be more reminding not to forget special aspects, but not giving something like a full description. So I am hesitating, if this will help to save significant time while improving quality. Any experience with it or other recommendations for templates?
I've never liked any of the templates I bought before. When these companies make these template, they make them so generic that its not really helpful. My recommendation is to start creating some of these documents and stripping out the first one and make that as your template.
 

Vetty007

Starting to get Involved
#3
Thank you for this feedback and the recommendation to break the technical file down, which we already do. Wow one year with 15 engineers, that is a quite hight effort.

I do not expect, that the templates are more than generic, but I would be happy for some explanations and recommendations what needs to be taken into account to not forget aspects. Instead of starting from zero, I was thinking it could be better to start with such a template. Of couse this depends on the price for the templated related to its quality.
 

Junn1992

Quite Involved in Discussions
#4
I'm not sure about man hours planning, but starting with the basic regulatory requirements first will be good. And along the way as you fill in the details, a RA/QA trained person will logically identify things that have to be done. For example, material A was used in the manufacturing process. Then aha! Do we have a process or documentation for qualification of material A form the supplier, and do we have a quality agreement with material A supplier. Stuff like that.
 

Vetty007

Starting to get Involved
#5
Thank you for the advice how to proceed, but working like this is possibly part of my problem as I did such things just beside other work, so that I didn't really recognize the time I spend for this task. As I track my time now, I can say that I have underrated a lot of tasks regarding the spended time and this is one of my reasons why I am asking this question :) Also everyone has another working style and pace, so it is also interessted in terms of compareability.
 
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