To minimise the risk of delay, we need to know the finish date and work in the backward direction as studied in the lecture this week. The PM should know how much time each task requires in the proces...

Risk/benefit ratio for a medical device manufacturers will be all the possible benefits of the device which would come along with a number of possible associated risks. These risks and benefits have t...

Since a milestone was missed it may have an impact on the entire project team and the various departments involved mainly the R&D. The PM will have to consider the more amount of time that will be...

Having the project team and risk management team would provide the ability to assess the risks associated with the project better and having a good overall sense of the project would allow the team to...

In my opinion, if the probability of risk is analyzed to be high then an analysis needs to be done about the costs involved in getting those risks eliminated. If the risks can be avoided within a sma...

According to me the factors that can help detect the status of the project and allow us to have a rough estimate of the time frame about the project would be having timely progress and status reports ...

Interpersonal skills is an extremely important aspect in order to be successful apart from having an equally balanced technical knowledge. Having an effective interpersonal skills can result in making...

In my view the best way to have a design review approval faster is by sending in the documents well ahead in time to the review meeting attendees well in advance as Dr. Simon mentioned so that the att...

Project managers are found in almost all sort of organizations. The project manager is responsible for the tasks involved from the beginning phase of the project to the closure of a project which incl...

Initiating a project is definitely a crucial task as it in general clarifies the objectives of the project and what is needed to achieve those object and does not necessarily involve starting work on ...

Verification and validation have an association but with some important differences.It is important to look into Verification and Validation in the early stages of design which is when developing requ...

As explained in the lecture videos of this week there are 3 types of organizational structures. First, the Functional Organization which has a dedicated team with members having shared skills and know...

Using an unapproved medical devices is allowed in a case where clinical trials are supposed to be submitted as claims for a pre-market approval (PMA) but with only a small group of people and with the...

The FDA's CDRH (Center for Devices and Radiological Health) follows a set of protocols to classify medical devices as class 1, class 2 or class 3 device depending on the risks involved with the device...

I do agree that interpersonal and technical skills do go and in hand or as a ratio of 50:50. Lacking in one of these can have drawbacks. Having really good technical skills and not being able to get i...