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 project cycle. The project manager. In terms of…   Read more»

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 device does not get damanged between the time it…   Read more»

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 project the project team will identify…   Read more»

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 process or product quality or cost are not as efficient and…   Read more»

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 beginning internally, we purchase a…   Read more»

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 timeline including major project milestones and…   Read more»

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 to simplify FDA regulations has…   Read more»

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 that is absorbed into…   Read more»

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 and they have not before, they will…   Read more»

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 have life cycle management responsibilities related exisiting…   Read more»

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 have always used Microsoft project…   Read more»