Design and Development of Products and Processes

Process and Product Design and Development discussion discussions. Design Verification and Validation included.
Discussions
M
Testing criteria - where to place
Replies
2
Views
168
Maximics
S
ASTM F2077-18 vs ASTM F2077-03
Replies
0
Views
96
SquirrellyGirly
K
  • Redirect
Is it possible to avoid the OQ?
Replies
–
Views
–
N/A
E
Sample size for design verification of variable in single use device
2 3
Replies
20
Views
5,228
Firdausom87
M
V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device)
Replies
2
Views
562
yodon
M
Design Control - Outsourced Process Requirements
Replies
8
Views
3,789
armani
A
Verification protocol example
Replies
2
Views
670
indubioush
S
Traceability of requirements to design and risk
Replies
3
Views
568
chris1price
R
Medical Device - Change manufacturing plant
Replies
6
Views
775
RegulatoryUS_EU
R
Do we need issue ECN (Engineering Change Notice) towards updated Material Specification?
Replies
2
Views
560
John C. Abnet
D
Change Approval Requirements - Does every change need formal customer approval?
2
Replies
17
Views
1,192
Jim Wynne
E
Mentor for Test Method Validation (TMV)
Replies
2
Views
816
Emmhod
D
Device functionality over service life - Objective evidence required?
2
Replies
10
Views
948
indubioush
S
Documenting Design Verification Test Results (ISO 9001)
Replies
1
Views
1,271
Tagin
K
ERP System Software Validation - ISO13485 2016 4.1.6
Replies
8
Views
1,829
Fat Larry
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