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 initi...

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 a...

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 th...

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...

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...

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...

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 aut...

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 fi...

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 re...

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, ...

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 doe...

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 prob...

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 ...

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...

Hello everyone,I am Wonbum Sohn, and a PhD student in Biomedical Engineering at NJIT.Here is my LinkedIn profile: Looking forward to connecting with you all 🙂