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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
D
Proving Substantial Equivalence in Software Medical Devices
Replies
2
Views
212
MDRexpert
Ron Rompen
2D matrix issue - Parts (machined steel) returned from the customer
Replies
0
Views
110
Ron Rompen
R
A Rational Basis for Design Verification
Replies
2
Views
242
Ronen E
S
ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning
Replies
2
Views
309
Watchcat
E
Functional Gage for TOP applied at RFS
Replies
5
Views
202
John Predmore
F
Conversion of coordinate dimension holes to position dimension
Replies
3
Views
236
optomist1
E
Sample size for design verification of variable in single use device
2
Replies
19
Views
2,089
Ronen E
T
Sample Size for Design Validation
Replies
4
Views
637
Ronen E
A
Engineering change validation - Companies that have no design responsibility
Replies
5
Views
3,522
DeeDeeM
G
Design and development of user centric audit report visualisation tool
Replies
5
Views
1,289
GTBroomfield
L
Managing design projects: New Medical Device Project or Change
Replies
1
Views
272
somashekar
C
  • Redirect
Deviation in Design verification
Replies
–
Views
–
N/A
M
Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs?
Replies
2
Views
265
somashekar
B
Validation of a Pressure Decay Leak Tester for a Medical Device
Replies
2
Views
2,323
eguevara
M
Does a CDR (Critical Design Review) have to have a moderator that is unconnected to the team?
Replies
4
Views
553
Sidney Vianna
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