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»

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?

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»

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?

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»

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»

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»

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»

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»

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»

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»

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?

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»

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»

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»

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?

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.

What preparations will help people who want to get a job in the project management department?
Are there any prerequisites that must be met?