Medical Device Courses | sp2387 | Activity

sp2387 replied to the topic "What it an NCMR" -

Wed, 15 May 2019 21:47:11 -0400

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… Read more»

sp2387 replied to the topic "Sponsorship for companies" -

Wed, 15 May 2019 21:47:10 -0400

sp2387 replied to the topic "Priorities for Projects" -

Wed, 15 May 2019 21:47:10 -0400

sp2387 replied to the topic "How to make good relation with vendors" -

Wed, 15 May 2019 21:46:33 -0400

To maintain good relations with vendors the manager should keep in touch with them regularly at the first place. Contacting them at regular intervals and often meeting them in person. Checking on the status of the resources that vendors is… Read more»

sp2387 replied to the topic "Overworked Americans vs. Motivation" -

Wed, 15 May 2019 21:46:32 -0400

sp2387 replied to the topic "Engineer vs. Manager" -

Wed, 15 May 2019 21:46:32 -0400

sp2387 replied to the topic "Communication Management" -

Wed, 15 May 2019 21:45:59 -0400

sp2387 replied to the topic "Single Source/Dual Source" -

Wed, 15 May 2019 21:45:59 -0400

sp2387 replied to the topic "Procurement Management" -

Wed, 15 May 2019 21:45:58 -0400

According to this weeks simulation the thought process of procurement management has been initiated. I had a good clear process for the selection of goods, sources as the vendors and their costs. Finding the vendors that provides the required specification… Read more»

sp2387 replied to the topic "Gantt chart" -

Wed, 15 May 2019 21:45:28 -0400

The tasks are interdependent so the overlapping is done in same category to track both of them. While in the different categories there may be subprojects,subprograms or subportfolios that can be dependent when merged further. There has to be monitoring… Read more»

sp2387 replied to the topic "Team Development" -

Wed, 15 May 2019 21:45:27 -0400

sp2387 replied to the topic "planned value vs actual costs" -

Wed, 15 May 2019 21:45:27 -0400

planned value is the value that should have been earned during that term. It defines that a percent of work should have been done in a particular given term. This value when calculated helps to determine that, Is the project… Read more»

sp2387 replied to the topic "Design Change Request" -

Wed, 15 May 2019 21:44:57 -0400

The project manager, system analyst and the device designer all should review each proposed designs and change according to what action is needed. The following topics should also be considered: Design change and its cost effects. Timeline affected due to… Read more»

sp2387 replied to the topic "Estimating Project Timeline" -

Wed, 15 May 2019 21:44:56 -0400

I belive that the measurements and control meetings are are great way to keep everyone updated. There are updates to every chage in design, documents and also the work done is discussed. This are the controls of the changes and… Read more»

sp2387 replied to the topic "It's the Right Thing To Do" -

Wed, 15 May 2019 21:44:09 -0400

There are many devices that exists where they do not have ISO standards but still maybe in use. I believe that ISO are mandatory because any device that can endanger a person’s life must not be used. Tgey are just… Read more»

sp2387 replied to the topic "Design validation" -

Wed, 15 May 2019 21:44:08 -0400

Design validation ensures that the device meet user needs and its intended uses. It is a design control activity that happens when the design development process is at its last stage. Design validation includes every stage from initial production units… Read more»

sp2387 replied to the topic "Meeting Deadlines with Research" -

Wed, 15 May 2019 21:44:07 -0400

One approach is certainly decreasing the time for animal studies. Reduced clinical trial can save some time to finish with the project as they take a lot of time for clinical trials and their results. Project risk comparatively increases. A… Read more»

sp2387 replied to the topic "Communication and Responsiveness" -

Wed, 15 May 2019 21:43:36 -0400

To cope up with the timeline for each and every member is necessary to avoid any unnecessary delay. For that a pin board should be kept attaching notes of all tge tasks. Not only that but also every update of… Read more»

sp2387 replied to the topic "Estimating Project Timeline" -

Wed, 15 May 2019 21:43:35 -0400

I think the tasks should be arranged in a way that if one task is completed early the other tasks that are independent of any other task that has to be completed during that time can be worked on. The… Read more»

sp2387 replied to the topic "Revising a Gantt Chart" -

Wed, 15 May 2019 21:43:35 -0400

I believe that there is a time factor not followed. As professor Simon mentioned that the early you start the early you finish and also matching the timeline of two different parts of the project is important that went wrong… Read more»

sp2387 replied to the topic "Are Missed Milestones really Bad?" -

Wed, 15 May 2019 21:43:02 -0400

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»

sp2387 replied to the topic "Risk Management Selection" -

Wed, 15 May 2019 21:43:02 -0400

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»

sp2387 replied to the topic "Risk Management" -

Wed, 15 May 2019 21:43:01 -0400

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»

sp2387 replied to the topic "Closing Phase" -

Wed, 15 May 2019 21:42:11 -0400

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»

sp2387 replied to the topic "Planning Phase" -

Wed, 15 May 2019 21:42:11 -0400

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»

sp2387 replied to the topic "Determining project priority" -

Wed, 15 May 2019 21:41:30 -0400

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»

sp2387 replied to the topic "Funding in Medical Devices Industry" -

Wed, 15 May 2019 21:41:29 -0400

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»

sp2387 replied to the topic "Possibility of Global Regulation of Medical Devices?" -

Wed, 15 May 2019 21:41:29 -0400

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»

sp2387 replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" -

Wed, 15 May 2019 21:40:42 -0400

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»

sp2387 replied to the topic "Initiating a Project Idea" -

Wed, 15 May 2019 21:40:41 -0400

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»

sp2387 replied to the topic "A advertising a sum of its parts?" -

Wed, 15 May 2019 21:40:41 -0400

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»

sp2387 replied to the topic "Update to Classification System" -

Wed, 15 May 2019 21:40:03 -0400

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»

sp2387 replied to the topic "Categorization of Medical Devices" -

Wed, 15 May 2019 21:40:02 -0400

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»

sp2387 replied to the topic "Unapproved Device" -

Wed, 15 May 2019 21:40:00 -0400

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»

sp2387 replied to the topic "Project management team" -

Wed, 15 May 2019 21:39:49 -0400

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»

sp2387 replied to the topic "''Quality Plan'' meaning ?" -

Wed, 15 May 2019 21:39:48 -0400

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»

sp2387 replied to the topic "Project Manager Skills" -

Wed, 15 May 2019 21:39:48 -0400

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»

sp2387 posted a new topic "Project budget and variance" -

Wed, 15 May 2019 16:36:35 -0400

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»

sp2387 posted a new topic "Execution phase" -

Wed, 15 May 2019 16:36:29 -0400

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»

sp2387 replied to the topic What it an NCMR in the forum Project Management Application: Clinical Trial

Wed, 01 May 2019 02:06:03 -0400

sp2387 replied to the topic Sponsorship for companies in the forum Project Management Application: Clinical Trial

Wed, 01 May 2019 00:57:16 -0400

The project sponsor is the person who pays for the project. Because he or she is paying for the project, they get to decide on the project scope, schedule and budget. They’re the ones really taking the big decisions. The project manager makes sure things get done. The project manager takes the sponsors decisions on the scope, schedule and b…[Read more]

sp2387 replied to the topic Priorities for Projects in the forum Project Management Application: Clinical Trial

Wed, 01 May 2019 00:46:54 -0400

I believe that priorities can be more then one. As we studied in the pert chart that tasks are interdependent on each other then you have to complete both the task with same priority in order to accomplish the project on time. Priorities greatly depends on time while time matters when it comes to dependency of the tasks the priorities become…[Read more]

sp2387 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial

Thu, 25 Apr 2019 15:45:21 -0400

sp2387 replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial

Thu, 25 Apr 2019 15:25:01 -0400

I Believe that american workers maybe working a good amount of hours but not because of any peer pressure. They work because they are motivated as well as they get paid what they deserve for their work. I belong to India and there we have work more comparatively to the american corporate and moreover with this kind of work load they don’t get paid…[Read more]

sp2387 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial

Thu, 25 Apr 2019 15:13:20 -0400

I will choose to be a project manager. I would like to work as a manufacturing engineer for first to get experience in an industrial environment. I need some technical experience to know how it works in this kind of environment and the I would like to move forward with the managing part. Because after all you need to know how any work is done…[Read more]

sp2387 replied to the topic Communication Management in the forum Project Management Knowledge Areas

Thu, 18 Apr 2019 18:45:56 -0400

The matrix of power can help out here. The most powerful person according to the matrix has to communicate as everyone relies on their orders and so is mostly listened to in the whole project team. The most information with no emotions can be safely shared via email. If you want to share your latest sales reports or schedule a time to get…[Read more]

sp2387 replied to the topic Single Source/Dual Source in the forum Project Management Knowledge Areas

Thu, 18 Apr 2019 18:37:05 -0400

According to different simulations we have done till now I have learned that its all about the working and proportion of the chemicals used to make a solution or coating. If the chemicals used in coating works as they are supposed to it doesn’t if it is a different or same source. Since it does its work from all the reagents used to make the…[Read more]

sp2387 replied to the topic Procurement Management in the forum Project Management Knowledge Areas

Thu, 18 Apr 2019 18:21:28 -0400

sp2387 replied to the topic Gantt chart in the forum Project Management Process and Medical Device Development

Wed, 10 Apr 2019 14:43:01 -0400

sp2387 replied to the topic Team Development in the forum Project Management Process and Medical Device Development

Wed, 10 Apr 2019 14:35:07 -0400

After the team selection the project timeline is decided as a pert chart or gantt chart. Since the timeline is based on the days needed to work on every single tasks of the whole project a gantt chart can useful. The days of vacation or holidays can be fixed in the timeline and there should be an early start to aim for early finish. Even if there…[Read more]