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ivd (in vitro diagnostic) devices and reagens
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Threads Tagged with
ivd (in vitro diagnostic) devices and reagens
Discussion Thread Title / Thread Starter
Last Post or Poll Vote
Replies
Views
Forum
CE Marking IVDs produced under ISO 9001
Paperman
started this discussion on 22nd April 2013
23rd April 2013
10:40 AM
by
Sarah Stec
1
275
CE Marking (Conformité Européene) / CB Scheme
What is a reasonable level of QA Editorial Control?
(
1
2
3
)
ced001
started this discussion on 3rd April 2013
16th April 2013
10:29 AM
by
ced001
20
1,147
Quality Management Related Issues
IVD Registration requirements in Russia
RChoudry
started this discussion on 19th March 2013
19th March 2013
06:18 PM
by
Ronen E
1
311
Other Medical Device Regulations World-Wide
Brazil B-GMP Regulation Revision - Draft Portaria 622
(
1
2
)
Marcelo Antunes
started this discussion on 25th April 2011
20th February 2013
08:21 AM
by
TJ-Bom
8
1,785
Other Medical Device Regulations World-Wide
No Stability Standard on latest List of Harmonized Standards IVDD
Rocke
started this discussion on 5th September 2012
18th February 2013
10:25 AM
by
Pythagore
2
806
ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
IVD (in vitro diagnostic) Regulations in Srilanka
(
1
2
)
sreenu927
started this discussion on 4th March 2011
6th February 2013
02:26 AM
by
KewalJoshi
10
2,485
Other Medical Device Regulations World-Wide
Appropriate use of the REF symbol in IVD kits and kit components
MPiska
started this discussion on 4th February 2013
5th February 2013
03:51 AM
by
MPiska
2
310
Other Medical Device Related Standards
Brazilian - Medical Device Performance Evaluation Only - Registration Requirements
Paperman
started this discussion on 20th June 2012
23rd January 2013
08:50 AM
by
Marcelo Antunes
6
451
Other Medical Device Regulations World-Wide
Clinical Evaluation Reports per the new MDD 93/42/EEC amendment
(
1
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3
4
5
6
)
lilybef
started this discussion on 2nd March 2010
29th December 2012
09:22 PM
by
drewsky1
41
10,331
EU Medical Device Regulations
Are IVD Distributors subject to "Qualification" under our Quality System?
qawatchdog
started this discussion on 12th May 2011
20th December 2012
11:07 AM
by
Proriv63
4
798
US Medical Devices (21 CFR part 820)
South Korea IVD Medical Device Classifications
(
1
2
)
kimberley
started this discussion on 17th August 2012
30th November 2012
03:18 AM
by
SQ2012
13
1,497
Other Medical Device Regulations World-Wide
A "sieve" inside a pot for seperating Tissues from Fluids - IVD or not?
rob73
started this discussion on 14th August 2012
27th November 2012
05:06 AM
by
Ron Boumans
6
507
EU Medical Device Regulations
Proposal of EU IVD regulation and IEC 62304
Marc_G
started this discussion on 22nd October 2012
17th November 2012
07:31 AM
by
Erik Vollebregt
5
703
IEC 62304 - Medical Device Software Life Cycle Processes
IVDs: Expiry Date on internal product standards
AbsoluteBeginner
started this discussion on 24th October 2012
11th November 2012
07:09 AM
by
Stijloor
1
443
Manufacturing and Related Processes
Laboratory Use Only Software: What does this imply?
Paperman
started this discussion on 19th October 2012
24th October 2012
01:43 AM
by
v9991
3
465
Other US Medical Device Regulation Topics
Comparative Study - 510(K) IVD Device
A.I.C
started this discussion on 26th September 2011
22nd October 2012
05:31 AM
by
Rocke
7
893
US Medical Devices (21 CFR part 820)
Risk Management Files for IVD (Invitro Diagnostic Reagent) Kits
Peeter.k.varkey
started this discussion on 9th October 2012
10th October 2012
08:20 AM
by
Peeter.k.varkey
3
637
ISO 14971 - Medical Device Risk Management
Transfer of CE Mark
(
1
2
)
Jo1974
started this discussion on 20th September 2012
5th October 2012
01:21 AM
by
Bioramani
9
1,107
CE Marking (Conformité Européene) / CB Scheme
IVD Medical Device Product Registration in Myanmar
esh14
started this discussion on 2nd October 2012
4th October 2012
02:59 AM
by
esh14
3
549
Other Medical Device Regulations World-Wide
IVD Medical Device Product Registration in Indonesia
esh14
started this discussion on 2nd October 2012
3rd October 2012
11:06 PM
by
Ronen E
2
450
Other Medical Device Regulations World-Wide
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