Medical Device and FDA Regulations and Standards News

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FDA guidance on non-sterile Medical Device Packaging
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4
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166
monoj mon
M
Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re
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7
Views
1,081
Helen_H
JoCam
FDA Registration for Sub-contract manufacturers
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2
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121
mihzago
M
FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard
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0
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109
Mark Meer
S
IEC 62304 software costs and time
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2
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125
silviaguerra
Z
IEC 60601-2-25; Frequency response test
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0
Views
81
Zameer
M
Informational EU – Official position on EUDAMED delay
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4
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801
Richard Houlihan
L
Proof of Concept Studies - Do we need to comply with SAE reporting?
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3
Views
336
Raisin picker
C
GUDID Device record history
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2
Views
212
monoj mon
D
Supplier Quality - How to classify a supplier level
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7
Views
365
duff999
M
Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means
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9
Views
760
Weeder
C
List of MDSAP Auditing Organizations
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1
Views
356
Jim Wynne
S
Requirements for "Claims Guide" for medical devices
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6
Views
783
SGquality
M
Informational US FDA Final and update guidances – Software
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2
Views
529
duinyk
C
FDA Establishment registration - Buying some medical devices from another manufacturer
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5
Views
926
monoj mon
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