Menu
Home
Forums
New posts
Search forums
What's new
New posts
All posts
New media
New media comments
Latest activity
Media
New media
New comments
Search media
Resources
Latest reviews
New resources
Search resources
Attachment List
Log in
Register
What's new
Search
Search
Everywhere
Threads
This forum
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Home
Forums
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
ISO 13485:2016 - Medical Device Quality Management Systems
ISO 13485 - Medical Device Quality Management System Requirements for Regulatory Purposes - (ISO 14969 has been replaced by ISO 13485:2016).
Prev
1
…
Go to page
Go
72
73
74
75
76
…
Go to page
Go
219
Next
First
Prev
74 of 219
Go to page
Go
Next
Last
Filters
Show only:
Loading…
Q
Questions about the Risk-based approach to QMS processes
QE1993
May 4, 2018
2
Replies
17
Views
5K
Aug 21, 2018
QE1993
Q
Intuitive Quality Design and Documentation Systems
pbojsen
Aug 3, 2018
2
Replies
12
Views
3K
Aug 20, 2018
normzone
N
S
Where to keep Enterprise Resource Planning software (ERP) Validation Records
snoopy2017
Aug 16, 2018
Replies
1
Views
1K
Aug 16, 2018
Marcelo
M
S
Expiry date vs. Best Before Date - Reagents
SpartanBio
Jul 31, 2018
Replies
9
Views
4K
Aug 15, 2018
Edward Reesor
M
Some possible misunderstandings on the application of ISO 13485
Marcelo
Jul 30, 2018
2
Replies
10
Views
8K
Aug 14, 2018
Marcelo
M
S
When should a note-to-file be used in a QMS vs Deviation Report
snoopy2017
Aug 10, 2018
Replies
1
Views
3K
Aug 11, 2018
Ajit Basrur
N
Does 13485 auditor have a right to inspect non-CE products?
nantmel
Aug 6, 2018
Replies
5
Views
2K
Aug 8, 2018
ScottK
R
Clinical Trial to sell in the EU - Necessary or Not?
Rich Bass
Aug 3, 2018
Replies
5
Views
1K
Aug 7, 2018
Rich Bass
R
T
Logic that determines what production testing is needed
thirdplanet
Aug 6, 2018
Replies
2
Views
1K
Aug 6, 2018
thirdplanet
T
W
Design and Process Validation - Different?
Woodray
Aug 3, 2018
Replies
6
Views
3K
Aug 3, 2018
Woodray
W
S
Do suppliers of prototyping components need to undergo supplier qualification?
snoopy2017
Aug 2, 2018
Replies
3
Views
1K
Aug 3, 2018
Edward Reesor
R
Pest Control and Monitoring Required?
RCW
Oct 22, 2010
Replies
7
Views
7K
Aug 1, 2018
Deli88
D
P
Quality objectives - must they include CAPA and internal audit topic?
psp1234
Jun 15, 2018
2
3
Replies
28
Views
7K
Jul 23, 2018
Wolf.K
W
W
Shelf life and accelerated aging
Wolf.K
Jul 20, 2018
Replies
2
Views
2K
Jul 23, 2018
Wolf.K
W
Adding a new site to 13485 Certification
Dobby1979
Jul 9, 2018
Replies
4
Views
2K
Jul 20, 2018
lxuejing
L
Prev
1
…
Go to page
Go
72
73
74
75
76
…
Go to page
Go
219
Next
First
Prev
74 of 219
Go to page
Go
Next
Last
You must log in or register to post here.
Home
Forums
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.
Accept
Learn more…
Top
Bottom