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
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