Medical Device Courses | kk | Activity https://medicaldevicecourses.com/members/ka-kyung-kim/activity/ Activity feed for kk. Fri, 24 Apr 2026 21:58:15 -0400 https://buddypress.org/?v= en-US 30 hourly 2 903f58529874edd18bc8abd90cf484d5 kk posted a new topic "In case of recall" - https://medicaldevicecourses.com/activity/p/10804/ Wed, 15 May 2019 16:36:38 -0400 I know this lecture did not touch much of product recall. But, how should company/researcher response when there is recall request from FDA or other regulations? Are there different stages of severity of recall and how to react?

]]> b6124518312bb380df45511aa317b4b7 kk posted a new topic "Human resource management" - https://medicaldevicecourses.com/activity/p/10803/ Wed, 15 May 2019 16:36:37 -0400 I have one scenario I wonder about what happens in this case In human resource management, a team has been settled and worked on a project and in the middle of the process. The project should keep moving on to…   Read more»

]]> 7b2466757e47e8fddecb6d2af566de55 kk posted a new topic "Gantt chart" - https://medicaldevicecourses.com/activity/p/10801/ Wed, 15 May 2019 16:36:36 -0400 On the gantt chart, why is it important to have multiple overlapping tasks going on in parallel? I understand within a same category, to make a smooth and fast work process, tasks overlap and process in parallel. But why does…   Read more»

]]> 574c38f47e4fb6624abab541c593a5b5 kk posted a new topic "Medical device" - https://medicaldevicecourses.com/activity/p/10776/ Wed, 15 May 2019 16:36:26 -0400 As far as I know, bandage should be gone through 510K or regulated by FDA. It sounds like it is categorized as a medical device. But it is not for diagnose tool, treat disease or affect structure in human. Not…   Read more»

]]> 4581edfcedc2baf46657b88c7eca0385 kk started the topic In case of recall in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10213/ Mon, 29 Apr 2019 18:44:55 -0400 I know this lecture did not touch much of product recall. But, how should company/researcher response when there is recall request from FDA or other regulations? Are there different stages of severity of recall and how to react?

]]> 0 04b25d6149f628a43461e6b00114909e kk started the topic Human resource management in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10133/ Mon, 22 Apr 2019 17:00:56 -0400 I have one scenario I wonder about what happens in this case
In human resource management, a team has been settled and worked on a project and in the middle of the process. The project should keep moving on to finish by deadline. One of team member is having maternity leave for 3 months. She is the only one who knows how to deal with her work. In…[Read more]

]]> 0 e66b7cc35bbee95571365536002487b6 kk started the topic Gantt chart in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/10004/ Thu, 04 Apr 2019 15:26:25 -0400 On the gantt chart, why is it important to have multiple overlapping tasks going on in parallel? I understand within a same category, to make a smooth and fast work process, tasks overlap and process in parallel. But why does it also same for within different categories?

]]> 0 7feb23856d979cd6fd5538290fe71635 Ka Kyung Kim started the topic Medical device in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9389/ Fri, 01 Feb 2019 18:53:47 -0500 As far as I know, bandage should be gone through 510K or regulated by FDA. It sounds like it is categorized as a medical device. But it is not for diagnose tool, treat disease or affect structure in human. Not all of products getting 510K are not medical device or they are still medical device?

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