There are different leadership styles that a PM can implement but it all comes down to whether they want to be loved or feared as a leader. Every good leader will inspire and set clear expectations fo...

A detailed plan is always going to include sub-plans that require planning with different areas within the project. There are many different components and plans that goes into a medical device so it ...

@nm523njit-edu The key requirement for this is to establish clear communication channels between project managers, regulatory affairs, and upper management. Regular updates on regulatory progress, pot...

First, the adequate predicate of that device needs to be found which will be the first starting point to figure out the product code and regulation number for the medical device. For this, utilize the...

The main solution to this would be either getting outside help using consultations or educating yourself on the topic. It is crucial to learn the biologics and drugs side of any medical component to e...

Another topic that is unique to medical devices include a robust quality management system or ISO 13485:2016 standards. This standard requires that a quality management system is implemented to meet t...

The PDCA cycle varies with different specialties and the companies but the overall principle provides the framework for how problems should be addressed and mitigated. In manufacturing engineering, th...

From a business standpoint, having a smaller and more experienced team is better than having a larger team where there is not enough work to go out to everyone. At least where I have worked, there wer...

Events held in anything considered non-professional, especially in the context of medical industry, can be considered an unreasonable location. Events held in resort locations, exotic destinations, or...

Verbal contracts are still legally binding if they have elements of validity. The problem with verbal contracts though is that people misunderstand each other causing disputes and other legal problems...

There are also some restrictions where patients can not give gifts to their physicians to. It carries a risk of subtle biasing to the care of that patient. According to the AMA, doctors are supposed t...

The matrix completely depends on the organizational culture, project, and preference of the company overall. Where I currently work, most of the PMs do not have the power to make major decisions on a ...

I'd say middle management, which includes any type of manager or director, because they have to maintain the operations of their team. More than that, they have to innovate to improve performance of t...

I currently work in a matrix organization as well and the program managers would recruit people from different departments for their program. This organization works really well because there is no ne...

The thing is some risks are relatively minor and have a very low probability of occurring. However, high probability risks need to considered and approaches should be taken to minimize the damage it m...