Medical Device Courses | Wonbum Sohn | Activity https://medicaldevicecourses.com/members/wonbum-sohn/activity/ Activity feed for Wonbum Sohn. Fri, 24 Apr 2026 21:58:15 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d2ca14864768f06f6a48b382e1ddfcdf Wonbum Sohn posted a new topic "Regulations in cases such as pandemics" - https://medicaldevicecourses.com/activity/p/25916/ Sun, 01 May 2022 00:27:31 -0400 In the case of diseases that has a global pandemic like COVID-19, I have seen simplified regulations to produce products rapidly. In this case, I am wondering what kind of change there is in the initiating and planning phase of…   Read more»

]]> ad2c0bf318c1a1e8715dcc36553bb3d5 Wonbum Sohn posted a new topic "Clinical trials when exporting medical devices to other countries." - https://medicaldevicecourses.com/activity/p/25915/ Sun, 01 May 2022 00:11:04 -0400 When exporting medical devices to other countries, how much does a report stating that the product has passed clinical trials in the previous country affect clinical trials in the country where they are exporting?

]]> 388af2c5b022e1dae70ad9815ecb9aa5 Wonbum Sohn posted a new topic "How do most companies tend to solve the problem?" - https://medicaldevicecourses.com/activity/p/25914/ Sun, 01 May 2022 00:09:04 -0400 When purchasing products through vendors, I think that most companies will include a clause to impose a penalty on the vendor when a certain level of quality is not guaranteed in their contract. If there is no the clause related…   Read more»

]]> 9525c7a483a2e9c6aab9a6bd043625e8 Wonbum Sohn posted a new topic "How to manage and train low performers in common companies?" - https://medicaldevicecourses.com/activity/p/25823/ Sun, 24 Apr 2022 16:22:32 -0400 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?

]]> 3b73363f1aaa6885486c4d6092afbb3c Wonbum Sohn posted a new topic "How to manage contracts with external clinical trial management teams?" - https://medicaldevicecourses.com/activity/p/25822/ Sun, 24 Apr 2022 16:19:52 -0400 Smaller companies would not have clinical trial management teams. In this case, it will be necessary to contract with a company that specializes in clinical trial management, but it would be difficult to properly conduct the contract and to manage…   Read more»

]]> 598b3f05b6e9e5295bdddce635c7d20e Wonbum Sohn posted a new topic "Methods to make a time and budget planning in the clinical trial" - https://medicaldevicecourses.com/activity/p/25821/ Sun, 24 Apr 2022 16:09:53 -0400 As the clinical trial procedure is complicated due to the many regulations, I think that the process of creating a time and budget plan related to the clinical trial will be more complicated than that of other managements. What methods…   Read more»

]]> c9f56b42de45f410d58077c65910ae3d Wonbum Sohn posted a new topic "Tools and techniques in project management" - https://medicaldevicecourses.com/activity/p/25665/ Sun, 17 Apr 2022 21:00:42 -0400 I have heard that tools and techniques are used in the process of planning and managing many sub-processes of project management. To what level does the program help? I am wondering if the program automatically set the date and budget…   Read more»

]]> da348093acee42ddd98e3182413f0629 Wonbum Sohn posted a new topic "Bottom up or top down estimation" - https://medicaldevicecourses.com/activity/p/25664/ Sun, 17 Apr 2022 20:54:50 -0400 I learned that there are bottom up estimation and top down estimation in the time and budget planning phase and that there are their own advantages and disadvantages. In the real project management field, which one is preferred or used,…   Read more»

]]> 47519a766e9f2211e1470eb5ad017f94 Wonbum Sohn posted a new topic "Quality control in small projects." - https://medicaldevicecourses.com/activity/p/25662/ Sun, 17 Apr 2022 20:52:28 -0400 I heard that quality control is conducted in large corporations or large projects, but it is not done well in small projects. I think quality control is important in product development. Is there a reason not to implement it in…   Read more»

]]> 13434d622f84ed471fab61459301b6d0 Wonbum Sohn posted a new topic "How people try to follow the changing trend." - https://medicaldevicecourses.com/activity/p/25519/ Sun, 10 Apr 2022 22:03:07 -0400 I think the regulatory criteria will change slightly depending on social issues and times. If I get to work on regulatory, I think I will have to follow these changes well. I am wondering how people, who are working in…   Read more»

]]> fe494779a7ed3d0f4079832dfda33388 Wonbum Sohn posted a new topic "How do the FDA manage" - https://medicaldevicecourses.com/activity/p/25518/ Sun, 10 Apr 2022 21:50:57 -0400 Through this simulation, I learned that different companies have different evaluation methods for toxicity tests and the test results may be different. It would be possible that a specific company does not sign a contract with a company that gives…   Read more»

]]> 782d7183c7b4e05c5cb9134e092a4986 Wonbum Sohn posted a new topic "Different results from each test companies." - https://medicaldevicecourses.com/activity/p/25517/ Sun, 10 Apr 2022 21:44:10 -0400 If a product has a problem in the verification and validation executed by the contracted company while a product has been passed in its own verification and validation, how do companies solve its problem in the real industry?

]]> 16c43f22b748971db3d42b65e8062594 Wonbum Sohn posted a new topic "The scale and process depending on different kinds of changes" - https://medicaldevicecourses.com/activity/p/25179/ Sat, 26 Mar 2022 14:29:27 -0400 I learned that the There are ‘Non-essential Design Change’, ‘Design Change Number’ and ‘Engineering Change Order’ in types of changes. I am wondering how the scale, the time required or the procedure of changes differs according to each change type in the…   Read more»

]]> 23df3940adc516f3dc09e8a1a7dc0896 Wonbum Sohn replied to the topic "Monitoring and Controlling Planned Value" - https://medicaldevicecourses.com/activity/p/25178/ Sat, 26 Mar 2022 14:21:05 -0400 I think that whether a company exceeds the planned value or keeps it depends on how much experience a company has in project management. Basically, we cannot accurately predict what will happen in the future. However, depending on how many…   Read more»

]]> c8c0f6cd986eaa2f47297c134c15cde7 Wonbum Sohn replied to the topic "Making connections between people and schools" - https://medicaldevicecourses.com/activity/p/25177/ Sat, 26 Mar 2022 14:07:46 -0400 Hello everyone,I am Wonbum Sohn, and a PhD student in Biomedical Engineering at NJIT.Here is my LinkedIn profile: https://www.linkedin.com/in/wonbum-sohn-17a453aaLooking forward to connecting with you all 🙂

]]> a1a46689e2e28f74ccdb7d1ac7f0c48a Wonbum Sohn posted a new topic "The power of the board of directors" - https://medicaldevicecourses.com/activity/p/24996/ Mon, 14 Mar 2022 01:02:46 -0400 I know that stakeholders also have a board of directors. However, in the case of the board of directors, the understanding of the project is likely to be lower than that of those who directly conduct and manage the project….   Read more»

]]> 05151f9508499e44e13c6793165776f7 Wonbum Sohn posted a new topic "Personnel evaluation when succeeding project but delaying." - https://medicaldevicecourses.com/activity/p/24994/ Mon, 14 Mar 2022 00:59:52 -0400 I think that there would be some cases that although the project has been successful, the project have been delayed or costs have increased during the project. In this case, what is the ratio of positive and negative aspects of…   Read more»

]]> cf407d055df0b70ac36a0a69fcccd92b Wonbum Sohn posted a new topic "Companies efforts in the executing step" - https://medicaldevicecourses.com/activity/p/24991/ Mon, 14 Mar 2022 00:55:44 -0400 I think that the project team would be able to falsify project progress to cover up their design mistakes in the executing step. In general, what kind of efforts do companies do to check whether the project is progressing properly?

]]> c63afa666e5404f74c282eacb4e504d0 Wonbum Sohn posted a new topic "In planning, the method to calculate each task duration." - https://medicaldevicecourses.com/activity/p/24842/ Mon, 07 Mar 2022 02:32:21 -0500 When scheduling tasks, how is the expected duration of each task calculated?
It seems that the time required for a similar task for each project will be different.

]]> 9071eccdb092dcaae5857044b335f0e9 Wonbum Sohn posted a new topic "What you need to get a job in project management" - https://medicaldevicecourses.com/activity/p/24840/ Mon, 07 Mar 2022 02:21:10 -0500 What preparations will help people who want to get a job in the project management department?
Are there any prerequisites that must be met?

]]> abcacbf05ac831fadf835b0424fad8db Wonbum Sohn posted a new topic "Tendency for project management in medical devices field" - https://medicaldevicecourses.com/activity/p/24839/ Mon, 07 Mar 2022 01:47:04 -0500 I think Project Management is very important in Medical Devices field. I am wondering in medical devices field, if the companies are likely to create the department within their companies for project management, or are likely to contract with a…   Read more»

]]> 0c5e1fae4cab04aa4d3551afebda6331 Wonbum Sohn replied to the topic "Importance of Stakeholders" - https://medicaldevicecourses.com/activity/p/24629/ Sat, 26 Feb 2022 23:05:33 -0500 I think it difficult to judge which one is more important. The investor is the person who supports the budget for the project, and the manager is the person who manages the project to keep it going. The project will…   Read more»

]]> 470fd671d918c2d0ad9534eb33accad7 Wonbum Sohn posted a new topic "How to set days related to task scheduling" - https://medicaldevicecourses.com/activity/p/24628/ Sat, 26 Feb 2022 22:58:37 -0500 Through the class, I was well aware that project team sets early start day, early finish day, late start day, and late finish day when scheduling tasks. By what criteria are early start days and late finish days determined?

]]> 4dcd0ccec5b3515fd86071954efa4ed5 Wonbum Sohn replied to the topic "Penalization for Going Over Budget and Time?" - https://medicaldevicecourses.com/activity/p/24627/ Sat, 26 Feb 2022 22:54:11 -0500 I think it should be handled differently depending on the reason. As people work, they will certainly encounter the unexpected event. If punishment is imposed even for justifiable reasons, members of the organization will be reluctant to participate in the…   Read more»

]]> 0df9ad43e7aec12770e567de3daff0ea Wonbum Sohn replied to the topic "Probability of failure" - https://medicaldevicecourses.com/activity/p/24532/ Sun, 20 Feb 2022 23:49:30 -0500 In modern society, a lot of products have been released and are still being released. The case of creating a completely different new product are unlikely. Therefore, there would definitely be products on the market that have similar functions or…   Read more»

]]> e2bdaf765d55c1216029e88beae13b3c Wonbum Sohn posted a new topic "Pros and cons related to risk management and project management" - https://medicaldevicecourses.com/activity/p/24530/ Sun, 20 Feb 2022 23:36:37 -0500 I heard that the members of project team can be included in a risk management team. What are the pros and cons of separating the risk management team from the project management team? What are the pros and cons of…   Read more»

]]> c4af92f5c8bcd8d69d41ec3f75670ded Wonbum Sohn replied to the topic "Project Management Process" - https://medicaldevicecourses.com/activity/p/24529/ Sun, 20 Feb 2022 23:30:38 -0500 I also think the executing processes are the more important step. Although the planning phase is important, we cannot anticipate and prepare for everything possible. If there is something that needs to be fixed as the work progresses, fixing it…   Read more»

]]> 020c1bd64cca06fcbab727f7a249ca8b Wonbum Sohn posted a new topic "Should procedures or standards for verification and validation tests be approved by the FDA?" - https://medicaldevicecourses.com/activity/p/24458/ Sun, 13 Feb 2022 22:27:07 -0500 In the medical devices field, should procedures or standards for verification and validation tests be approved by the FDA?

]]> 9b0843cf3fda74960ef1f370e3c08fa1 Wonbum Sohn posted a new topic "Examples of budget changes due to DSD testing" - https://medicaldevicecourses.com/activity/p/24457/ Sun, 13 Feb 2022 22:24:22 -0500 During verification test to check the specification, input and output from DSD, what is the probability of having to change the budget for additional experiments? Also, how well are the budget change proposals accepted?

]]> c08d5119c3540d567cc2c5e8a76eef4e Wonbum Sohn posted a new topic "Maintaining the licenses for manufactures" - https://medicaldevicecourses.com/activity/p/24456/ Sun, 13 Feb 2022 22:23:22 -0500 If entering the project management or regulatory department of a company that makes and sells medical devices, what does employees usually do to maintain the licenses for manufactures from the FDA? Is the maintenance procedure very complicated?

]]> b0b32e7cc9a79a952a04a120dda4fa6e Wonbum Sohn posted a new topic "Types of organizations" - https://medicaldevicecourses.com/activity/p/24376/ Sun, 06 Feb 2022 23:37:32 -0500 In medical device management, which type of functional organization, project-based organization, or matrix organization is most common?

]]> 21610dd84eb9329d26149e36b2cb3d9f Wonbum Sohn posted a new topic "Risk management" - https://medicaldevicecourses.com/activity/p/24374/ Sun, 06 Feb 2022 22:56:33 -0500 It seems that risk analysis and risk management are important, but that they are a very difficult part for those who lack experience. If I work in the project management field, will I receive training in risk analysis or rick…   Read more»

]]> 1a9e2c53a6e556a22a849a7a48928bac Wonbum Sohn posted a new topic "Verification and Validation" - https://medicaldevicecourses.com/activity/p/24373/ Sun, 06 Feb 2022 22:49:05 -0500 I’ve heard about verification and validation through lectures, but I’m still not sure about the difference between the verification and validation. What exactly is the difference between verification and validation?

]]> c3f881c0ed2a539bb4a2eb0619882e01 Wonbum Sohn posted a new topic "Works of a project manager and a program manager?" - https://medicaldevicecourses.com/activity/p/24279/ Fri, 28 Jan 2022 17:04:21 -0500 9224def7e60d1d7494618efaeaaee9f3 Wonbum Sohn replied to the topic "Regulatory Project Management" - https://medicaldevicecourses.com/activity/p/24272/ Fri, 28 Jan 2022 17:04:16 -0500 Thank you for good information. However, I do not yet understand exactly the relationship between the regulatory professionals and project management. Should the person who works project management, such as a project manager, be well aware of the regulatory rules?…   Read more»

]]> 6aa6fd0d32be601e1216f51de312d8f7 Wonbum Sohn replied to the topic "Roles of the Regulatory Department" - https://medicaldevicecourses.com/activity/p/24271/ Fri, 28 Jan 2022 17:04:16 -0500 I think it is difficult to conclude which department is more important because both departments are important. I would like to work in post-market management. I have heard from developers before that very few products continue to survive on the…   Read more»

]]> 2de4a4561723ca750552ee2ae5296aac Wonbum Sohn posted a new topic "Class 2 device and 510(k)" - https://medicaldevicecourses.com/activity/p/24270/ Fri, 28 Jan 2022 17:04:14 -0500