Medical Device Courses | Wonbum Sohn | Mentions

ag2265 replied to the topic "Should procedures or standards for verification and validation tests be approved by the FDA?" -

Mon, 23 Jan 2023 03:16:04 -0500

Hi @wonbum-sohn I recall from taking Professor Simon’s other course BME 684 where he mentioned standards of verification and validation which are essentially protocols that must be followed when creating a medical device. These two standards are different where verification… Read more»

AJY6 replied to the topic "How to manage and train low performers in common companies?" -

Tue, 26 Apr 2022 20:18:49 -0400

Posted by: @wonbum-sohn In order not to undermine employee motivation, companies need to manage underperforming employees. However, I think there is a limit to fire low-performing employees every time. How does the companies usually manage and train underperforming employees? I… Read more»

ac825 replied to the topic "Importance of Stakeholders" -

Tue, 01 Mar 2022 03:13:49 -0500

@wonbum-sohn I think you make a great point about how a good manager can make a big difference. however I still believe that the investor is still more important. This is because I have had first hand experience with how… Read more»

mmodi replied to the topic "Class 2 device and 510(k)" -

Mon, 31 Jan 2022 03:03:47 -0500

Thank you @wonbum-sohn for creating this post and for everyone who has responded. As mentioned in other threads, I am working on a point of care device for early cancer screening. Although the targeted biomarker of interest for the device… Read more»