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 contract and that person cannot…   Read more»

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 course is awesome, I got to know all the…   Read more»

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 capable of dealing with great project size and complexity….   Read more»

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 of power. Functional Heads may or may…   Read more»

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 successful. It…   Read more»

Other risk management methods are: – Risk indicator scales: Works as a support for subjective judgement when the content and commercial environment of your project is routine and the scales have been calibrated. Often misused by inexperienced personnel who try…   Read more»

The Risk assessment meeting is an important part of any project. The risk assessment meeting should be a formal meeting conducted during the project’s planning process. First step is the project manager has to send a meeting invitation to all…   Read more»

Another risk factor to be considered for making decisions concerning product availability, compliance and enforcement is factors for the assessment of medical device benefits. Benefit, as described by the potential benefit factors, may change over time. FDA may assess the…   Read more»

The verification protocol of every medical device or products has to consist of doing a test suitable for the desired purpose, then check the results. Based on the output of the test, it is decided if this product or device…   Read more»

I think design verification is important, because in the initial stages of design verification is a key quality assurance technique. As the design effort progresses, verification activities become progressively more comprehensive. Verification is a theoretical exercise designed to make sure…   Read more»

Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities…   Read more»

Even though I don’t have any experience in the field yet, doing research on this topic was interesting. There are a couple of steps that have to be taken into account before building a Gantt Chart. First we have to…   Read more»

There are some important factors to keep in mind in order to have a complete DHF. First we have to keep up with it as you go. Throughout the process, you have to keep an eye on every change you…   Read more»

Minutes are used to document business conducted at a meeting. Typically, they will describe the events of a meeting, include a list of participants, record issues discussed and decisions made concerning these issues. Minutes can also be used as proof…   Read more»

I think it doesn’t depend on the role you are taking in the clinical research, having a clinical background will always be a plus for all the roles. However, the necessity of the clinical background is more important, or in…   Read more»

If I was involved in clinical research, I’d want to have the role of a Clinical sponsor. A sponsor is a person who takes responsibility for and initiates a clinical investigation. The sponsor may be individual or a pharmaceutical company….   Read more»

Nothing in this world is perfect, anything has to have pros and cons, but we have to put the most effort to make more pros than cons. In this case the pros of clinical research are: you may get promising…   Read more»

Now medical device companies are directly contacting consumers, but not necessarily through the traditional television airways. Companies such as Medtronic and Boston Scientific have patient education websites advertised on social media to deliver information about their products and the conditions…   Read more»

Vision Statement is a general broad statement about what the company wants to accomplish. It communicates company values and purpose. It is basically a company’s road map, indicating both what the company wants to become and guiding transformational initiatives by…   Read more»

The best marketing plan has to use the modern technology to make customers participate with the company. Social media is a huge way to make customers participate in a marketing process, because the product would be well advertised across the…   Read more»