Medical Device and FDA Regulations and Standards News

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GUDID registration
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2
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633
EmiliaBedelia
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D
Labeling requirements for sending products for testing
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5
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381
yodon
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J
Over labeling CE marked products
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1
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355
DanMann
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D
Does a 510(k) for a mobile medical app need to include a wireless technology/communication section?
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0
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400
DeviceMan
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K
Management of Outsourced QC?
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5
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658
Enternationalist
Enternationalist
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Process Validation Before Commencement of Clinical (Investigation) Trials
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1
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578
dgrainger
dgrainger
A
Research Use Only Products
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3
Views
502
DanMann
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H
What are the requirements in case a medical device company goes bankrupt (class II)?
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1
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340
DanMann
D
E
FDA's thinking about whether the chemical analysis (such as extractables/ leachables) is required for a Class II MD
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2
Views
379
Emma2010
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M
ESTAR 510(k) Submission
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2
Views
921
EmiliaBedelia
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E
Sensors used in medical devices
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0
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353
errethakbe
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Aliken
Registration veterinary medical device (laser) requirements
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3
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897
Softness and duck
Softness and duck
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ASTM F2100-23
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0
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581
Moricona
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D
Is MDDS a Medical Device in all countries ?
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4
Views
466
DanMann
D
W
Labeling requirements for warranty replacement device
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3
Views
512
DanMann
D
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