Gap analysis of new start-up company technical documentation

#1
Hi all,

I was challenged to perform a gap analysis of technical documentation for a new star-up company that is developing a medical device (probable high risk). They have a lot of reports and registry from the development phase but never done taking into account the regulatory demands. My question is:

1 - How many hours do you think is needed to review documentation considering that they have everything well organised?

Cheers
 
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#2
Hi all,

I was challenged to perform a gap analysis of technical documentation for a new star-up company that is developing a medical device (probable high risk). They have a lot of reports and registry from the development phase but never done taking into account the regulatory demands. My question is:

1 - How many hours do you think is needed to review documentation considering that they have everything well organised?

Cheers
Its a tough question to be answered, there is lot of subjectivity around what you consider "everything well organised" to what other may consider...again this question can be answered differently by personnel with different level of quality experience.

If I was in your shoe, the first thing I would be doing is spending some time may be a day perform FDA QSIT audit to identify the glaring obvious systemic process and design control issue if any....as a first step!
 
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