I think that the success of working in large or small groups and with people from different backgrounds depends on the particular project, its objectives and the dynamics of the team. Some of the adva...

It is very important to understand the differences between the three classes early on in a project because it can help save money and time. Typically, Class I devices are low-risk devices, which are k...

Drugs and medical equipment are very important for the safety of our health. Medicines and medical devices have many differences that may include their mechanism, their interaction with the human or a...

Both the PMA and the 510(k) are the most important documents required by the FDA for medical devices to receive market approval. PMA is technically required for all Class III devices. Typically, medic...

Gift-giving to doctors is a delicate and complicated topic, with different national and local laws and standards applying. In my opinion, it's fine to give a physician small gifts that are under $100,...

This is a very good question. In my opinion, if you invite a physician to a dinner to talk about the product you can promote and they bring their spouse to the dinner, it is very disrespectful to only...

When I first started this class I thought it would be more of a medical device prescription class. However, I was surprised and at the same time happy to learn about the different jobs Biomedical Engi...

Depending on personal preferences, professional aspirations, and strengths, one may choose between Upper and Middle Management. Some people are ideally suited for upper management because they have a ...

Establishing a project team is an essential first step in making sure a project is successful. Creating a project team that works requires a deliberate approach that considers each member's unique cap...

In my opinion, the best organizational structure is the matrix organization. I think this way because the resources in this type of organization are very well managed. The same resources can be used f...

ISO 14971 is the primary ISO rule that regulates risk management for medical equipment. ISO 14971 is a worldwide standard that offers a framework for controlling the risks connected to medical devices...

An example of avoiding risk is when a specific substance used in the urinary catheter was found to have the potential to cause allergic reactions in certain patients . The company chooses to modify th...

Risk assessments are required for medical devices. The regulatory framework for medical devices must include risk assessment as a fundamental element in order to guarantee the long term efficacy and s...

Like most of the comments, I believe that companies are taking their corporate responsibility very seriously. Companies are now expected to conduct business ethically, addressing matters like honesty,...

To guarantee an efficient project management procedure, a number of elements should be taken into account when arranging tasks and generating a Gantt chart. As most have indicated, timeliness is a key...