Chapter 2 of the PMBOK discusses stakeholders. Identifying stakeholders is a process that occurs throughout the entire project lifecycle and the project manager is expected to manage these stakeholde...

The project proposal or project charter is the document approved by Management for a project to get underway. It actually will not usually include a Gantt Chart but instead a rough estimate of the ti...

Now that we are 1 year in to this administration and the announcement to overhaul the FDA regulations, I thought this might be a interesting topic to revive. How do you think President Trump's promise...

I have had the opportunity over the last 10 years to work with Drug-Eluting Coronary stents. These stents are delivered by a catheter, used to prop open the coronary artery and are coated with a drug ...

Medical Device Regulatory affairs in the global economy is highly complex and challenging. To grow, medical devices companies must expand to new markets. Increasingly, each country's regulations are ...

Early on in the initiation and planning phases it is important to understand GMP requirements and how they relate to the project. For example, if your company is now developing a combination device a...

I work for Cordis, part of Cardinal Health and the organization is highly matrixed. I report to my supervisor within supplier quality and also serve on project teams for various internal projects. I ...

I have worked in the medical device industry for the last 14 years. The last 10 years have been at Cordis which recently became part of Cardinal Health (previously part of Johnson and Johnson). I hav...