Medical Device Product Requirements Document (PRD) a "Design Review"?

R

RSantos

Registered Visitor
#1
#1
Is the review of a medical device Product Requirements Document (PRD) a "Design Review"?

Background: We developed a PRD for a client. Before the PRD was finalized, the engineers that prepared the document, an independent reviewer, and the client met to review the draft PRD. Minutes from the meeting were issued, and after incorporation of the action items from the meeting, the PRD was signed. I call this meeting a "Design Review". Am I correct?
 
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Sidney Vianna

Sidney Vianna

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Staff member
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#2
#2
Re: Review of the PRD - Design Review?

RSantos said:
Is the review of a medical device Product Requirements Document (PRD) a "Design Review"?

Background: We developed a PRD for a client. Before the PRD was finalized, the engineers that prepared the document, an independent reviewer, and the client met to review the draft PRD. Minutes from the meeting were issued, and after incorporation of the action items from the meeting, the PRD was signed. I call this meeting a "Design Review". Am I correct?
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As you describe, I would not call this activity a design review. What you describe is a review of the design input data. Paragraph 7.3.2 of ISO 9001:2000. Design review(s) happens later in the design development cycle.
 
Y

yodon

Staff member
Super Moderator
#3
#3
Since you state that it's for a medical device, I presume the QSR would apply. As such, it would be a design input and a review is required. I've commonly seen requirements review records 'lumped' under the Design Review heading in the DHF. So whether you want to call it a Design Review or something else, the evidence that the review occurred is required under the QSR (i.e., treat the minutes as a quality record).
 
R

Roland Cooke

Quite Involved in Discussions
#4
#4
You agreed the Design Inputs with the customer. You have a (quality) record of that discussion.

It is possible - perhaps even probable - that Design Inputs will be amended or added/removed.

When you discuss the outcome of your development efforts (i.e. Design Outputs), compared to what was agreed you would try to do, that is Design Review.

This Review can perhaps occur at multiple stages throughout the development cycle. It's much better to think of Design Review as a process rather than a meeting.
 
F

fireonce

#5
#5
I couldn't agree with you more!
If you keep the records,you can comply with the requirements of "design review"
 
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