So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the international health authorities require...

Often times the business tries to push for new products or changes to existing products to be submitted to the FDA and cleared in order to meet the budget for that year or to meet a certain timeline t...

There is nothing guaranteed when it comes to design verification and validations, and especially when it comes to new product development. For sustaining projects, usually design verification should b...

Having the same regulations worldwide seems to be an easy solution to launch one product across all regions/countries without spending extra time trying to meet all those different regulations, howeve...

I believe that there still can be an ideal PM. I feel like soft skills are the key for success of any project manager; problem solving, communication, and time organization are the most important soft...

Even though engineering and design plays a huge role in coming up with a new project/product, the business need is far more important. Before presenting a project, a market research has to be done to ...

Any project within the medical device industry requires some sort of design verification and validation work in order to ensure that the product is safe and effective. Timing can be very critical to t...

I agree, it is been really hard lately communicating things between team members due to the lack of face-to-face communication. Everything works best when you have the opportunity to just stop by some...

Repeated mistakes happen all the time due to associates leaving the company or moving to another position within the company without sharing their previous experience with the rest of their project te...

Strict policies are always a good routine to follow, to have a successful company so everything would run smoothly. I mean it is kind of understandable that you can only get a gift for the physician t...

I wouldn't trust or rely on any verbal agreement. no one should start any project based on verbal agreement, because if someone makes a promise verbally and breaks it, it is not considered a broken co...

Dr. Simon, Thank you for such an amazing course. I've learned a lot from this course, especially because I'm majoring in Mechanical Engineering not Biomedical Engineering. The overall quality of this ...

I think the matrix organization is the most efficient. The matrix organizational structure has a great influence on the project management. The matrix evolves to fill a need for an organization capabl...

I work currently in a matrix organization, where employees have dual reporting relationships - generally to both a functional manager and a product manager. Project Managers may or may not have a lot ...

I think forming a project team is one of the hardest steps to take for the project to take place. Choosing the right people in the right department will help to make the project go smooth and be succe...