In a previous Project Management course we were asked to identfy the personality styles of our team members, analyze how those styles might conflict a...

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 pr...

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 compani...

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 c...

Project planning is very important and critical to the success of a project. Project plans are absolutely living documents that will be updated throu...

I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following. Industry standards Regulations ...

In my company I support contract manufacturing. So while we also have very similar processes to those mentioned above for internal design changes, I ...

In addition to doing a strong stakeholder analysis and getting input from those stakeholders into the risk planning process, it is important to make s...

When developing packaging for medical devices there are two primary concerns. The first is maintaing product integrity throughout the shipping and sto...

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 ...

I have recently come across another example of a challenge in the global regulatory involvement and that involves continuous improvement. When a prod...

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 whe...