Medical Device Design and Development Plan Procedures help wanted

N

nbull

#1
Hi,
I'm putting together a Design and Development plan.
The tasks and timelines side of things I'm fine with.
Does anyone have an example of the kind of information which should be present for "Procedures to be followed by reviewers", "Controls for design documentation" and "Notification activities"?
Many thanks.
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Hi,
I'm putting together a Design and Development plan.
The tasks and timelines side of things I'm fine with.
Does anyone have an example of the kind of information which should be present for "Procedures to be followed by reviewers", "Controls for design documentation" and "Notification activities"?
Many thanks.
Hello and welcome to the cove :bigwave:

I'll have a quick go on your question, then we can continue if I'm at the right direction, OK?

"Procedures to be followed by reviewers" - Design Reviews, Risk Management Reviews etc. [Do you already have the associated documented SOP's for such?]

"Controls for design documentation" - formal processes for implementing competent critical review and formal approval of design output documents (technical drawings, assembly procedures etc.)

"Notification activities" - Could be activities associated with preparation and submission of required documents for regulatory clearance purposes (510k etc.).

Hope this is of some help.

Cheers,
Ronen.
 
N

nbull

#5
Thanks both for your useful replies.
We do already have SOPs and various other documents that I can reference for this, which will save me time.

Attachments saved, thanks AnaMaria, useful doc to have.
 
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