Documentation hold during submissions?

#1
Hi All,
Not sure this is the right forum to answer this question, but surely somebody faced this issue.
I began working as QA Manager in a new medical device company a while ago.

It turns that the RA department does not allow updating documents that were submitted for NB/health authorities' approval.
For instance, the risk analysis - once approved and submitted- cannot be touched until the regulatory agencies completes the review, and this may take even months.

This completely paralyzes further R&D activities, due to such limitations.
Have to confess I never saw something like that in 25 years of experience in Pharma, Bio and Med Devices.
While I can understand the probable reason, I've never seen such a limitation on other companies.

Questions:
1- Is anybody familiar with this?
2- If so, how do you cope with this limitation?

Thank you all in advance,
Claudio
 
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