Budget cuts doesn’t affect the cost estimation of the project. However it does affect the scope or quality of the project. A good project manager needs to resist that pressure and make sure that any cuts in project spending are…   Read more»

In the closing phase closing phase process, all documents of the project both in terms of device delivery, and project management delivery must be completed. Project actual results are reported and documented, project contracts are closed, and lessons learned documents…   Read more»

I think all the factors listed are very important for a project, and I think the most important thing is to Develop clearly defined plans with assigned responsibilities. For each task in thee project must be identified in your data…   Read more»

Actually all the factors listed above are a very important tools for a successful product manager, but I think its very important for the product manager to Stay informed about industry and market data, because better pricing and better service…   Read more»

Interpersonal skills is very important in negotiation. I believe a good negotiator should have some qualifications- for example: – Preparation and planning skill. – knowledge of the subject matter being negotiated. – Ability to think clearly and rapidly under pressure…   Read more»

Introduction stage of a product life cycle, its a very important stage in the product life cycle, because the product manager should focus on marketing,advertising, pricing , distribution, and promotion to sell the product. In the introduction stage limited competition,…   Read more»

The FDA recalled GE MRI in 2015. Reason for Recall: Some MRI units may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU). The MRU is one method used to shut off…   Read more»

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, Approval, and IQ OQ & PQ. Because of the…   Read more»

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 a…   Read more»

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, in the monitoring and controlling processes accomplish three things: -…   Read more»

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 standards. As a project manager you need to plan for the unexpected things!.Things happen during…   Read more»

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 have created…   Read more»

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 as planned. A…   Read more»

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 create a combination product that, when implanted in a…   Read more»

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 fully verify the results. Validation is…   Read more»

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 validation is to make sure the…   Read more»

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 inspection and test, the process shall be validated”. The validation…   Read more»

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 risk management, for example, risk of Toxicity,…   Read more»

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 context. When everyone agrees with the statement, the…   Read more»

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 on any project, it’s…   Read more»