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Design and Development of Products and Processes

Process and Product Design and Development discussion discussions. Design Verification and Validation included.
Discussions
A
Verification protocol example
Replies
2
Views
217
indubioush
S
Traceability of requirements to design and risk
Replies
3
Views
271
chris1price
R
Medical Device - Change manufacturing plant
Replies
6
Views
553
RegulatoryUS_EU
R
Do we need issue ECN (Engineering Change Notice) towards updated Material Specification?
Replies
2
Views
359
John C. Abnet
D
Change Approval Requirements - Does every change need formal customer approval?
2
Replies
17
Views
834
Jim Wynne
E
Mentor for Test Method Validation (TMV)
Replies
2
Views
595
Emmhod
D
Device functionality over service life - Objective evidence required?
2
Replies
10
Views
759
indubioush
S
Documenting Design Verification Test Results (ISO 9001)
Replies
1
Views
1,084
Tagin
K
ERP System Software Validation - ISO13485 2016 4.1.6
Replies
8
Views
1,576
Fat Larry
O
ISO13485 implementation - Are internal audits expected before stage 1 audit?
Replies
3
Views
891
outdoorsNW
G
Defining performance metrics for DFMA implementation
Replies
2
Views
869
g_dep1
J
A tale of two processes.
Replies
2
Views
544
Bev D
K
Analysis variation among the lots during cpk calculation.
Replies
1
Views
551
Miner
F
Flatness VS parallelism
Replies
6
Views
2,299
fisa
U
What is the process for making updates to our Processes?
2
Replies
11
Views
1,228
Jim Wynne
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