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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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Sticky
February 2013 Medical Device "State-of-the-Art" updates
Sam Lazzara
Feb 3, 2013
Replies
3
Views
4,802
Jun 3, 2014
Ronen E
Sticky
Medical Device Standards - Difference between IEC and EN Standards
Marc
Oct 27, 2011
2
Replies
13
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18,844
Oct 28, 2011
rob73
Discussions
FDA and Biocompatability Testing - Reviewer has requested implantation testing
lilybef
Jan 23, 2019
Replies
7
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156
Yesterday at 12:25 PM
planB
K
Differences between EN ISO 11607-1:2009 vs. 2017
kwak2
Wednesday at 1:06 AM
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1
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83
Yesterday at 9:56 AM
planB
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ISO 10993-5:2009 vs. ISO 10993-5:2003 differences - Cytotoxicity Testing
mwa
Jun 18, 2009
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5
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8,868
Yesterday at 8:24 AM
planB
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What are the differences between TIR 13004:2013 and TIR 33?
marran
Feb 7, 2019
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2
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69
Feb 7, 2019
Ajit Basrur
S
ISO 5356-1 - 22 mm ring gauges and test laboratories for an Anesthetic connector
Sneha
Jan 31, 2019
Replies
1
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75
Jan 31, 2019
Pads38
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Per the FDA regulations can a medical device be class I despite that it is sterile?
Nissim Shaked
Jan 22, 2019
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2
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81
Jan 22, 2019
Nissim Shaked
ISO 10993-1:2018 has just been published
planB
Aug 28, 2018
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1,314
Jan 9, 2019
Jnks_Meddev
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Ethylene Oxide Sterilization Validation-Reference Load
erj526
Jan 7, 2019
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118
Jan 8, 2019
Ed Panek
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Device Standards - Managing Changes to existing standards that apply to our devices
funkgirl
Jan 6, 2019
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110
Jan 7, 2019
somashekar
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Biocompatibility on aged devices
Freddo
Jan 16, 2018
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900
Dec 12, 2018
planB
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Cytotoxicity at the end of life-time
Lenka
Nov 24, 2018
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160
Nov 27, 2018
planB
IEC 82304-1:2016 - Health Software - why not?
MrTetris
Nov 7, 2018
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5
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236
Nov 19, 2018
Jesse Shearin
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EN 285:2006 and EN 285:2015 - Can we test according to EN 285 ourself?
StefanTop
Nov 2, 2018
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179
Nov 7, 2018
StefanTop
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Regulatory Affairs Certificate (Medical Device and Pharmaceuticals
nmquality
Apr 14, 2015
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6
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3,253
Nov 1, 2018
immi
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Implementation of ISO 27001 as part of the GDPR compliance journey
lzanini
Sep 20, 2018
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2
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381
Oct 5, 2018
AndyN
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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