* 510 K Submission Process (updated 2024-11-30) ~ youtor.org

510 K Submission Process (updated 2024-11-30)

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Duration: 3:26
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Duration: 2:16
63 views | 8 months ago
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Duration: 30:04
475 views | 11 months ago
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Duration: 17:14
224 views | 4 months ago
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Duration: 29:14
310 views | 8 months ago
What is a split predicate [upl. by Noir]
Duration: 21:41
333 views | 9 Sep 2023
How to Prepare a 510k Quality Submission [upl. by Pantia57]
Duration: 1:07:58
1.2K views | 12 Jul 2016
Is an FMEA mandatory for the 510k submission [upl. by Charmane93]
Duration: 31:03
414 views | 22 Apr 2023
Interactive 510k Submission Process [upl. by Anirtal94]
Duration: 1:25
2.6K views | 30 Oct 2023
510k and Substantial Equivalence Why Do So Many Get It Wrong [upl. by Karlen37]
Duration: 1:34:11
129 views | 4 months ago
WI007 Cybersecurity Requirements Webinar [upl. by Evelin548]
Duration: 53:05
3.2K views | 24 Sep 2021
Cybersecurity Webinar  Learn what the FDA wants in your 510k [upl. by Hufnagel]
Duration: 1:08:44
994 views | 18 Mar 2023
Which biocompatibility tests do you need to do for a 510k [upl. by Rosmunda]
Duration: 28:35
414 views | 6 months ago
FDA Regulatory Pathways and Programs [upl. by Lauder]
Duration: 1:01:31
41 views | 3 months ago
Regulatory Roundtable Medical Device Made Easy Panel Discussion [upl. by Xavier]
Duration: 1:12:50
245 views | 27 Apr 2023
Avoiding Potential Issues with your 510k Submission [upl. by Ches]
Duration: 39:56
76 views | 8 months ago
Top Regulatory Mistakes Too Little Too Late [upl. by Nojed]
Duration: 2:40
246 views | 8 Oct 2018
ISO 109931 Testing Requirements  Amsterdam 510k Workshop [upl. by Lee614]
Duration: 10:49
687 views | 8 months ago
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Duration: 9:46
309 views | 5 months ago
Master Class  FDA PreSubmissions [upl. by Eicirtap]
Duration: 1:04:20
217 views | 4 Oct 2018
Labeling and UDI Requirements for a 510k Submission [upl. by Kaiulani]
Duration: 7:59
757 views | 4 Apr 2022





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