Activity | jp582 | Medical Device Courses

jp582 replied to the topic "Design Verification & Validation" – 5 years, 10 months ago

Design verification and validation are the procedure to check during medical device development process that the product meets the specific requirements and error free. Design verification is testing that the design output meets the design input and requirements you have… Read more»
jp582 replied to the topic "Design input sources" – 5 years, 10 months ago

Design input is the key point of medical device. If design input defined well during product development, it makes the rest of product development easier. Some sources state that establishing design input can take easily up to 30% of the… Read more»
jp582 replied to the topic "Important Part of DDP" – 5 years, 10 months ago

Design development plan(DDP) is a plan written by project manager, and it defines and describes all important aspects needed for the project. I think final scope statement is the most important part of DDP to provide understanding of project strategy,… Read more»
jp582 replied to the topic "What are Design Controls?" – 5 years, 10 months ago

Design control is required by FDA to check the medical device you design and develop is safe to use before you bring the product to market. Design Control is a procedure while developing a medical device to meet with specification… Read more»
jp582 posted a new topic "Six Sigma Green Belt Certificate" – 5 years, 10 months ago

As we have all heard about six sigma either through Dr. Simon’s lecture or outside. Six sigma is a technique intended to improve business processes by reducing the probability of error or defect will occur. I would like to know… Read more»
jp582 posted a new topic "Engineering change order" – 5 years, 10 months ago

Hello Everyone, In this week’s lecture, Dr. Simon talked about different kinds of changes during monitoring and control phase. One of the change is Engineering change order which is a packet of documentation includes proposed change, list the parts or… Read more»
jp582 posted a new topic "how the PM handles budget cut?" – 5 years, 10 months ago

Hello everyone, Budget cut is the most common issue during the project, and it happens too often. It has negative impacts on staff of cutbacks, reorganization and sometime layoffs. In my opinion, sometime working under budget helps in situation later… Read more»
jp582 posted a new topic "How to initiate project successfully" – 5 years, 10 months ago

Hello Everyone, It is critical to know which steps can be taken to successfully go through project initiating phase as quickly and efficiently as possible. To be a good project manager, you should know how to initiate projects successfully, get… Read more»
jp582 posted a new topic "Human Factors study in combination products" – 5 years, 10 months ago

Hello Everyone, Human Factors study considered users to assess the adequacy of the combination product user interface design to eliminate or mitigate potential use-related hazards. Human factors study is perform to consider the complexity of the combination product and the… Read more»
jp582 posted a new topic "Alternatives dispute resolution" – 5 years, 10 months ago

Hello Everyone, As we all have little idea of legal aspects and how it works. We know outside of court settlement is best option which saves time and money, get more privacy and become less stressful. There are two types… Read more»
jp582 posted a new topic "Risk management methods" – 5 years, 10 months ago

As Dr. Simon has mentioned in this week video lecture, method to analyze risks and one of the method he talked about is Failure Mode, Effects, and Criticality Analysis (FMECA). FMECA is potentially utilized for failure and risks associated with… Read more»
jp582 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

I completely agreed with hiren rana. I also heard this through my internship at hospital dealing with medical instruments such as calibrating, perform testing and problem solving on devices. I was surprised by knowing that there are places where manager doesn’t know what his/her employees job and need which makes communication worse. I think it i…[Read more]
jp582 started the topic Six Sigma Green Belt Certificate in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

As we have all heard about six sigma either through Dr. Simon’s lecture or outside. Six sigma is a technique intended to improve business processes by reducing the probability of error or defect will occur. I would like to know everyone’s opinion or experience about Six Sigma.
Anyone who has six sigma green belt certificate how you utilize it? Wha…[Read more]
jp582 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

I expected fair pay and benefits should slightly be higher. I am surprised by number that only 32% and 22% people’s motivation fair pay and benefits. In my opinion, if the fair pay and benefits are not satisfying to the employees, then it would have negative impact on their work performance. My motivation is to work in challenging area or c…[Read more]
jp582 replied to the topic Change Requests During Clinical Trials in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

I would like add to above post. The sponsor is responsible for initially determining if the change meets the statutory criteria. This determination should be made by the person in the company responsible for such decisions, and should be based on the agency’s definition of credible information.
A change to the protocol to increase the sample s…[Read more]
jp582 replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

Team members are the main and the most important resource of each company. For achieving successful results, each leader needs to have a motivation strategy to create and maintain the spirit of enthusiasm among employees. If I would be a manager, I would like to see my team members to be motivated and especially I would make sure that everyone is…[Read more]
jp582 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago

Challenges motivate me the most. Challenges are not that many people enjoy because low odds of success with big sacrifices of time, effort and sometime money. However, I like challenges because it helps build my skill, inspires courageous acts, and tests my limits. After finishing those challenges successfully, it feels very rewarding and helps me…[Read more]
jp582 replied to the topic Procurement Management in the forum Project Management Knowledge Areas 7 years, 11 months ago

Choosing a vendor can be as simple as asking friends who they use for their business. Other, I would take certain steps to choose right vendor such as document my organization needs, identify the sources- do my own research, measuring supply performance, and communicate with different vendors and see how well they satisfy end-user. Other things, I…[Read more]
jp582 replied to the topic Discussion Topic: Risk Analysis methods in the forum Project Management Knowledge Areas 7 years, 11 months ago

Preliminary Hazard Analysis is a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product, or system. The tool consists of: (1) the…[Read more]
jp582 replied to the topic Discussion Topic: Costs and managing your investment in the forum Project Management Knowledge Areas 7 years, 11 months ago

The rate of return (R) is used as the discount rate for future cash flows to account for the time value of money. Companies may often have different ways of identifying the discount rate. Common methods for determining the discount rate include using the expected return of other investment choices with a similar level of risk, or the costs…[Read more]
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