Medical Device Academy
Medical Device Academy is a full-service QA/RA consulting firm for medical devices. Our goal is to help startup companies get their first device to market. We know you have a limited budget, so we post free training videos on this channel in addition to our paid webinars. On our website, we have a complete turnkey quality system for sale: medicaldeviceacademy.com/. We have dozens of clients from other countries that we are helping to obtain 510(k) clearance and to implement a quality system compliant with ISO 13485:2016 and applicable national regulations. We now offer FDA US Agent services at: fda-us-agent.com/. Live-streaming videos are hosted on this channel every Friday at 12:30 pm Eastern. If you have a topic you want us to talk about, please leave a comment under our discussion tab. Please don't forget to share videos with colleagues you think would benefit from our content.- 1:07
- 4 ай бұрын
Is formative human factors testing required?
- 1:24
- 4 ай бұрын
The essential elements of creating a Quality Plan
- 19:35
- 5 ай бұрын
When is too early to create a regulatory pathway?
- 9:23
- 6 ай бұрын
SYS-018, Complaint Handling Procedure & Webinar Bundle
- 14:10
- 7 ай бұрын
Medical Device Reporting Procedure (SYS-029) v0.2
- 1:43
- 8 ай бұрын
510(k) Tip - Snap a picture of your calibrated device
- 21:16
- 8 ай бұрын
How to manage Calibrated Devices
- 8:35
- 8 ай бұрын
How to Select an Animal Testing Lab
- 5:44
- 8 ай бұрын
A Short Tutorial on QMS Procedure Revision Numbers
- 1:37
- 10 ай бұрын
Hiring an Auditor
- 3:04
- 11 ай бұрын
Is the 510(k) course price per person or per company?
- 13:40
- 11 ай бұрын
How long does a 510(k) submission take to get cleared?
- 23:52
- 11 ай бұрын
How much does a 510(k) cost? - FY 2024
- 1:15:28
- 11 ай бұрын
How to you create a Design History File (DHF)?
- 10:30
- 11 ай бұрын
What training is required for quality auditors?
- 14:24
- Жыл бұрын
How to create a receiving inspection turtle diagram
- 43:42
- Жыл бұрын
7 Steps to Respond to an FDA 483 Inspection Observation
- 6:46
- Жыл бұрын
FDA Predetermined Change Control Plan (PCCP) Guidance for Artificial Intelligence (AI)
- 57:13
- Жыл бұрын
US Postmarket Surveillance Requirements for Medical Devices
- 1:25:47
- Жыл бұрын
EU Postmarket Surveillance Requirements for Medical Devices
- 4:11
- Жыл бұрын
What is the difference between a 510k and De Novo?
- 8:40
- Жыл бұрын
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