21 CFR Part 820 - US FDA Quality System Regulations (QSR)

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
Sidney Vianna
  • Sticky
FDA plans to use ISO 13485 for Medical Devices Regulation
2
Replies
13
Views
2,921
bkelly79
E
  • Sticky
Finding Medical Device Listing Numbers on the USA's FDA site
2
Replies
19
Views
41,545
Ronen E
K
  • Sticky
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
Replies
6
Views
5,600
Julie O
Marc
  • Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
Replies
0
Views
8,436
Marc
Ajit Basrur
  • Locked
  • Sticky
21 CFR Part 820 - QUALITY SYSTEM REGULATION
Replies
0
Views
13,203
Ajit Basrur
Discussions
A
Document Review and Document Approval --- 2 Signatures needed acc. §820.40?
Replies
6
Views
225
Tidge
S
Is any dissatisfaction over a Medical Device considered as a complaint?
Replies
8
Views
694
Cthames
P
Unrealistic Packaging Validation Sample Size
2 3 4 5
Replies
41
Views
2,365
Bev D
D
FDA Guidance on Computer Software Assurance versus 21 CFR Part 11
Replies
2
Views
156
Tidge
S
New to Repackaging/Relabeling!
Replies
1
Views
78
somashekar
L
Clinical Trial and Finished Devices
Replies
0
Views
72
lymphatik
S
Bringing a Medical Device Sample from a Foreign Country into the US
Replies
9
Views
4,566
Manel Mou
M
UDI (Unique Device Identification) Verification Requirements
Replies
9
Views
7,345
cklau
S
Looking for procedure on UDI (Unique Device Identification)
Replies
2
Views
1,130
cklau
R
FDA Under Pressure From Congress - Impact on pending 510(k)'s
Replies
9
Views
2,804
Kuldeep Singh
N
Traditional 510K Submission-Financial Certification or Disclosure Statement
Replies
6
Views
222
Nomad.David
S
Private Label Requirements, Manufacturer's Registration & Initial Importers
Replies
3
Views
1,081
Parul Chansoria
R
Role of Contract Manufacturer - MDRs (Medical Device Reporting)
2
Replies
10
Views
5,805
bamacajun
J
Rework or Recall
2
Replies
10
Views
439
Jen Kirley
J
Promoting and marketing of a non approved device
Replies
4
Views
206
Jkc3usc12
You must log in or register to post here.
Top Bottom