In the lecture, Professor Simon mentions scope creep. Scope creep is when there is project work being done or considered that is outside the original agreed upon scope of the project. An example mig...

In a previous Project Management course we were asked to identfy the personality styles of our team members, analyze how those styles might conflict and to come up with a set of ground rules for the p...

In Lecture 6 we were given examples of verification protocols and reports. One section I see missing from the report is deviations. I don't know that I have ever been part of a verification process w...

In my company, the Work Breakdown structure more closely resembles option 2. I have seen various degrees of success with this. I think one of the problems I see occur is that the people providing in...

About 6 years ago the company I work for was developing a next gen drug coated coronarystent. Due to competition, sales were falling from the companies first drug coated stent. The first stent used t...

So first of all, regulations are rarely released by surprise. When a government entity releases a new version of a regulation they generally give a company plenty of advance notice and time to comply...

Project planning is very important and critical to the success of a project. Project plans are absolutely living documents that will be updated throughout the course of the project. One way to mitiga...

I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following. Industry standards Regulations Previous projects / products Competitor products En...

Chapter 3 of the PMBOK states that process groups are not the same as project lifecycle phases. It states that all process groups could be conducted within any phase. For example clinical trials may...

In my company I support contract manufacturing. So while we also have very similar processes to those mentioned above for internal design changes, I will go into the process when we have a design cha...

In addition to doing a strong stakeholder analysis and getting input from those stakeholders into the risk planning process, it is important to make sure that risk management is done throughout the pr...

When developing packaging for medical devices there are two primary concerns. The first is maintaing product integrity throughout the shipping and storage process. This means we want to make sure the...

Hi, so here we are talking about two different kinds of Risk Managment Plans. In project management the Risk management plan is how we identify risk throughout the project. At the start of the proje...

I have recently come across another example of a challenge in the global regulatory involvement and that involves continuous improvement. When a product is launched, often times the manufacturing pro...

I have been in the medical device industry for 14 years and have worked on many aspects of design controls. Most of our recent projects have been where instead of developing a device from the beginni...