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sp2387 replied to the topic "Are Missed Milestones really Bad?" – 5 years, 10 months ago
I believe that missing a milestone at any point is bad. Sometimes it can cause a hell to the project and sometimes not. When it come to any project that is affected due to missing milestone it can causes company… Read more»
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sp2387 replied to the topic "Risk Management Selection" – 5 years, 10 months ago
One person working for multiple teams has its own pros and cons such as: Pros: It reduces artificial dependencies between projects. Reduces induced administrativeand context switching overhead. Increased domain knowledge and team cohesion. It improves visibility and clarify on progress…. Read more»
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sp2387 replied to the topic "Risk Management" – 5 years, 10 months ago
Risk management is process of identifying, assessing, reducing and accepting risks. Efforts to avoid, mitigate and transfer risk can produce significant returns. In a project risk there is a compliance risk that can greatly effect causing significant cost of changing… Read more»
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sp2387 replied to the topic "Closing Phase" – 5 years, 10 months ago
I read somewhere that closing phase has two important documents in the closure of the project. One is the formal project closure document and second is the lessons learned. Found it interesting and should be shared. Every project is different… Read more»
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sp2387 replied to the topic "Planning Phase" – 5 years, 10 months ago
Planning phase is the most important and basic phase according to me. If you are planning it should be practical because after all it has to be executed. Each and every step of any project should be planned that gives… Read more»
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sp2387 replied to the topic "Determining project priority" – 5 years, 10 months ago
I believe that if any project can wait to be done for that time it is not priority to complete it at that moment. Priorities are defined by timelines, if a project can wait while another project is currently been… Read more»
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sp2387 replied to the topic "Funding in Medical Devices Industry" – 5 years, 10 months ago
Funding is the most essential part undoubtedly on medical industry. Anything attached with medical can cost more due to its safety regulations. For use internally or externally on human being. To be compliant with these safety regulations are needed even… Read more»
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sp2387 replied to the topic "Possibility of Global Regulation of Medical Devices?" – 5 years, 10 months ago
There are ISO standards that are used by companies for launching any medical device in any country that doesn’t have their medical standards or if they are not clear enough. The countries that have their own medical regulation of medical… Read more»
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sp2387 replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" – 5 years, 10 months ago
Proposals always have high expectations. I believe in order to provide a successful proposal you have to give more than that is expected from you. To put on new things or ideas on proposal makes them different from other cliches…. Read more»
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sp2387 replied to the topic "Initiating a Project Idea" – 5 years, 10 months ago
I agree with Patricia. A project idea is tge gist of the whole project plus whole project relies on that in one way or other. I believe that to convince someone for any project with only an idea is not… Read more»
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sp2387 replied to the topic "A advertising a sum of its parts?" – 5 years, 10 months ago
I agree that advertising is a sum of its parts. It is like the company is conveying the functions of the part that is made for. In other words, any device that is made is approved by FDA on the… Read more»
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sp2387 replied to the topic "Update to Classification System" – 5 years, 10 months ago
Well ryan your way of thinking may be right but as we know FDA classification is more of risk based.Ibased.I believe that the device name looks like it must be class 3 device because it is attached to heart but… Read more»
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sp2387 replied to the topic "Categorization of Medical Devices" – 5 years, 10 months ago
Regulatory Standards for medical devices has a 3 class classification system that are class 1,2 and 3. They are classified on the basis of risk that is present while using them on a patient. As the class increases the risk… Read more»
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sp2387 replied to the topic "Unapproved Device" – 5 years, 10 months ago
The use of unapproved devices during emergency is allowed but is conditional. The emergency situation is when there is a life threatening disease or condition that requires immediate use and no available alternative for life threatening condition. In such cases… Read more»
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sp2387 replied to the topic "Project management team" – 5 years, 10 months ago
I believe that teamwork in the workplace is an important factor for project success. Teamwork is important because it creates human synergy. It amplifies the results of each member of your team such that the overall result is greater than… Read more»
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sp2387 replied to the topic "''Quality Plan'' meaning ?" – 5 years, 10 months ago
A quality plan is a document, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract. Quality plans should define Objectives, steps in the processes that constitute the… Read more»
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sp2387 replied to the topic "Project Manager Skills" – 5 years, 10 months ago
I believe that the first and important skills are planning and scheduling the project according to the requirements of the projects. furthermore project manager gathers and analyzes information to prepare status reports, Ensures that assignment and scheduling of work follow… Read more»
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sp2387 posted a new topic "Project budget and variance" – 5 years, 10 months ago
As per the given formulas of schedule variance and cost variance. The schedule variance if is positive then you are ahead of schedule and vice versa. For the cost variance positive the project is under budget and for negative it… Read more»
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sp2387 posted a new topic "Execution phase" – 5 years, 10 months ago
At this point there are number of important project documents. It covers aspects such as risks, actions, issues and decisions. These elements are kept in mind while working on the execution phase of the project. It is much easy to… Read more»
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sp2387 replied to the topic What it an NCMR in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
In any company ISO 9001 certified, managing non-conforming materials is a must. It is a must not only to satisfy the ISO requirements, but also to reduce costs and ensure product defects are recorded and handled appropriately. When you identify a product or material that does not match the specifications, you record it as a non-conforming…[Read more]
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