Medical Device and FDA Regulations and Standards News

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NRTL Certification for US
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0
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241
bethfulcher
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ISO13485 7.2.1 (d) User Training
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3
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826
DanMann
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Does a PLC (programmable logic controller) as a component of a medical device need software validation?
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6
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573
helles
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FDA Quality System Regulation Amendments
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273
indubioush
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US FDA 510k Clearance Complete!!!! Africa???
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4
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479
kjlcm
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Establishment Registration and Device listing - Wording of 807.20 (a) (6)
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4
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2K
Haresh
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Electronic QMS Validation?
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4
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471
Enternationalist
Enternationalist
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Transition period for manufacturers to adopt new versions of medical device standards - IMDRF
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1
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464
planB
planB
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UDI requirements on packaging
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1
Views
562
yodon
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Sidney Vianna
New Revision of IAF MD9 available - Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
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2
Views
661
Sidney Vianna
Sidney Vianna
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Establishment Registration for Q-Submissions
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1
Views
386
BuckeyeBurro
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MaHoDie
MDS2 and Cyber Security labeling
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4
Views
423
MaHoDie
MaHoDie
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Establishment Registration addresses
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1
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252
EmiliaBedelia
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Orca1
New FDA Product Codes in the last 3 months
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0
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314
Orca1
Orca1
MaHoDie
Computer System Validation for Analysis Tool for Clinical Investigation evaluation?
Replies
4
Views
338
Ed Panek
Ed Panek
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