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 that is related to the field. Maybe because if it was allowed to get a gift that is not related to the field, some physicians will get better gifts…[Read more]

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 be punished for breaking it. An oral contract, on the other hand, is a promise that has been plainly spoken and not…[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 steps that we go through before releasing a medical device. Before this course, I did not even know what is…[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. It has greatly added to the versatility and effectiveness of project management. The matrix…[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 not have a lot of power. Projects are done by project teams, and everything depends on how strong the matrix…[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 doesn’t matter if you have connections with these people or not, the important thing is you have to make sure all the team members have to…[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 to convert scales into dollar or time values
– Probability modelling: Model development…[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 the attendees well ahead of time, so that they can review it and be prepared when it is time for the m…[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 extent of benefit of a device by considering factors like: type of benefits,…[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 should move on to the next step or it requires redesigning or modifying. Any verification protocol should include: Purpose…[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 that no requirements are missed in the design. For some…[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 taking place over the life cycle of the product and…[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 identify the steps needed to complete the projects. Then we identify milestones within the projects. Next we identify the expected…[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 make and update the DHF accordingly. Second factor is to store it separately from your project file, because otherwise it will get messy with all the other…[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 that a meeting took place to provide reference for those who were unable to attend.the ICSA have…[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 other words it is required to have a clinical background, once you are dealing directly with patients. If you have that…[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. I think this is the most important role in clinical trial, because even though he is not directly working o…[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 new treatment methods that you cannot get outside clinical research, the new method may have less side effects than the usual care, you may be…[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 these products treat in a less direct approach to…[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 setting a defined direction for the company’s growth.
Mission Statement lays out…[Read more]