Product development phase is the most important role in the product life cycle. As Dr. Simon mentioned, in the development phase you start to do: Market Research, Design Control, Design Transfer, Appr...

First of all you need to think about the reason for any change, also if the change is essential or no?. If the change will add improvement to the project or or improvement for the device ? To evaluate...

As a PM for a medical device project (for example) it is important to keep projects on budget. As we have learned from Monitoring and Controlling phase lecture, that a positive Schedule Variance numbe...

In monitoring and controlling phase of the project management lifecycle ensures that the project performance is monitored and adjustments to the project schedule are made as needed. According to PMBOK...

Scheduling utilizes a combination of work breakdown structure and project information, these include: tasks, key tasks, project types, location, project characteristics,WBS, and time and staffing stan...

I think validation is the most important process in a design control. As a project manager you need to know what is validation mean and how you validate a product. You need to make sure the device you...

When it comes to a timeline change in a project, this will causing delay in the project. If you are a project manager, you need to create accurate project timeline, that will help you reach your goals...

An example of a combination product: Bone morphogenetic proteins (BMPs are a class of proteins) that induce bone formation. New technology in orthopedic repair combines BMPs with a carrier matrix to c...

As we learned from Simulation 2, ,the IQ, OQ, and PQ required for proper inspection. During the validation process all the data need to be analyzed and documented. You should analyze each input and fu...

Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the ...

Actually, the FDA reviews the validation of the manufacturing processes. According to 21 CFR 820.75, which states that "where the results of a process cannot be fully verified by subsequent inspectio...

An example for managing the risk for a medical device: There is a medical device called "PEMF: Pulsed ElectroMagnetic Field", this device is being used for bone simulation (bone healing). In terms of ...

As we learned, in the planning phase its important to do: 1- Scope Statement: the statement thoroughly describes the project, and objectives of the project . The statement also describes the project's...

Regarding to risk management, as we learned in Week 5, in project management plan you need to measure the risk, Assess, Evaluate, and finally how to manage the risk. By the time a risk actually occurs...

As Dr.Simon mentioned, if you failed to plan so you planning to fail. Planning phase is very important in any Medical Device project. Its important to identify critical interfaces in your project, res...