Medical Device Academy
6.27K subscribers
54:27
Software Validation Documentation for Medical Devices - FDA eSTAR
Medical Device Academy
462 views • 1 month ago
1:07
Is formative human factors testing required?
Medical Device Academy
111 views • 2 months ago
1:24
The essential elements of creating a Quality Plan
Medical Device Academy
65 views • 2 months ago
19:35
When is too early to create a regulatory pathway?
Medical Device Academy
162 views • 2 months ago
12:18
Where to find FDA software and cybersecurity submission requirements
Medical Device Academy
270 views • 3 months ago
9:23
SYS-018, Complaint Handling Procedure & Webinar Bundle
Medical Device Academy
203 views • 3 months ago
14:10
Medical Device Reporting Procedure (SYS-029) v0.2
Medical Device Academy
285 views • 4 months ago
1:43
510(k) Tip - Snap a picture of your calibrated device
Medical Device Academy
143 views • 5 months ago
21:16
How to manage Calibrated Devices
Medical Device Academy
193 views • 5 months ago
8:35
How to Select an Animal Testing Lab
Medical Device Academy
119 views • 5 months ago
5:44
A Short Tutorial on QMS Procedure Revision Numbers
Medical Device Academy
232 views • 6 months ago
46:31
FDA Cybersecurity Testing Requirements - Interview with Red Sentry
Medical Device Academy
1K views • 7 months ago
1:37
Hiring an Auditor
Medical Device Academy
110 views • 7 months ago
3:04
Is the 510(k) course price per person or per company?
Medical Device Academy
115 views • 8 months ago
13:40
How long does a 510(k) submission take to get cleared?
Medical Device Academy
380 views • 9 months ago
23:52
How much does a 510(k) cost? - FY 2024
Medical Device Academy
648 views • 9 months ago
1:15:28
How to you create a Design History File (DHF)?
Medical Device Academy
2.6K views • 9 months ago
10:30
What training is required for quality auditors?
Medical Device Academy
160 views • 9 months ago
14:24
How to create a receiving inspection turtle diagram
Medical Device Academy
506 views • 11 months ago
7:29
How to create a turtle diagram for the medical device servicing process
Medical Device Academy
333 views • 1 year ago
43:42
7 Steps to Respond to an FDA 483 Inspection Observation
Medical Device Academy
646 views • 1 year ago
6:46
FDA Predetermined Change Control Plan (PCCP) Guidance for Artificial Intelligence (AI)
Medical Device Academy
782 views • 1 year ago
17:02
How to create a turtle diagram for the document control process
Medical Device Academy
1K views • 1 year ago
57:13
US Postmarket Surveillance Requirements for Medical Devices
Medical Device Academy
1K views • 1 year ago
1:25:47
EU Postmarket Surveillance Requirements for Medical Devices
Medical Device Academy
2.1K views • 1 year ago
4:11
What is the difference between a 510k and De Novo?
Medical Device Academy
1.1K views • 1 year ago
8:40
SYS-041 Clinical Evaluation Procedure
Medical Device Academy
434 views • 1 year ago
19:08
510(k) eSTAR Webinar - Indications for Use and Classification
Medical Device Academy
621 views • 1 year ago
19:03
What is IEC TIR 80002-1:2009?
Medical Device Academy
875 views • 1 year ago
12:23
SYS-006 Change Control Procedure
Medical Device Academy
1.7K views • 1 year ago
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