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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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21 CFR Part 820 - US FDA Quality System Regulations (QSR)
21 CFR (Code of Federal Regulations) Part 820 related discussions.
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Finding Medical Device Listing Numbers on the USA's FDA site
Exact
Dec 3, 2009
2
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19
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32,695
Mar 28, 2019
Ronen E
Sticky
FDA plans to use ISO 13485 for Medical Devices Regulation
Sidney Vianna
Aug 30, 2018
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8
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1,585
Aug 31, 2018
Marcelo
K
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
kingkobra
Sep 25, 2013
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5,198
Oct 24, 2016
Julie O
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ISO 13485, ISO 14971 and other Medical Device Related Forums
Marc
Oct 18, 2009
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0
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8,047
Oct 18, 2009
Marc
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
Ajit Basrur
Apr 22, 2008
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12,434
Apr 22, 2008
Ajit Basrur
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Contracted Manufacture Company wanting to be able to design and manufacture own product.
love02eat
Jan 10, 2020
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130
Jan 11, 2020
Watchcat
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Writing a Pre-Submission to the FDA
venezia
Jan 9, 2017
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30
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6,371
Jan 10, 2020
love02eat
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Changing the Address in 510(K) Approved Product
Kuldeep Singh
Jan 8, 2020
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1
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66
Jan 8, 2020
Ronen E
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Per 21CFR 820.198 (b) - Justification for no investigation
BeckaH
Jan 3, 2020
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344
Jan 7, 2020
Watchcat
21 CFR Part 820 - FDA Label Requirements
Ed Panek
Jan 3, 2020
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103
Jan 6, 2020
Ed Panek
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510K - Trade Name Change
LOGI2004
Jan 2, 2020
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0
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94
Jan 2, 2020
LOGI2004
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How is Medical Device Number (MDL) assigned to companies?
QualityDean
Dec 27, 2019
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78
Dec 27, 2019
QualityDean
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Essential Design Output(s) and Design transfer
Chef100
Dec 19, 2019
2
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319
Dec 24, 2019
Chef100
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Complaints and not the legal manufacturer?
Jkc3usc12
Dec 16, 2019
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365
Dec 19, 2019
Ed Panek
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Establishment Registration - Specification Developer Quandry
Quality Mom
Jan 10, 2012
2
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17
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5,346
Dec 18, 2019
Ronen E
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Mislabeling - Consider this an FDA notified recall? CFR 806.10
Jkc3usc12
Dec 12, 2019
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131
Dec 15, 2019
Watchcat
J
KPIs or Metrics to Measure a New Complaint Handling Process
jlhaney63
Dec 12, 2019
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5
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129
Dec 13, 2019
Jen Kirley
Attachment browser
Looking for a Design Transfer Checklist
Ajit Basrur
Nov 2, 2018
Replies
2
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1,001
Dec 12, 2019
lindal
Q
Regulations for Medical Device Kit for Training Personnel?
QualityDean
Dec 11, 2019
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64
Dec 11, 2019
Ronen E
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When does the FDA consider a component a medical device?
reginawags
Nov 15, 2019
2
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386
Nov 20, 2019
Ronen E
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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