Activity | ial4 | Medical Device Courses

ial4 replied to the topic "Discussion Topic: Your organizational type" – 6 years ago

Hi, A organization structure defines a reporting relationship in company.I currently work in a functional organization. Once we get a project, we work as a team and submit the project on time .We do not have any communication with other… Read more»
ial4 replied to the topic "Factors Contributing to Risk Values" – 6 years ago

Hi, I do agree with the above discussion, Risk severity is categorized into three levels and includes a duration component. The three levels are medical device-related deaths or serious injuries, medical device-related non-serious adverse events, and medical device-related events without… Read more»
ial4 replied to the topic "Usability Risk Analysis" – 6 years ago

Hi, I did some research and in my opinion the best way to address risks is pseudo-quantitative method is probably the risk matrix, which classifies the likelihood of a risk in one category and the consequences in another category. The… Read more»
ial4 replied to the topic "Risk management and Labels" – 6 years ago

Hi, I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA’s premarketing risk assessment is intended to identify and quantify risks detected during clinical development and to evaluate how carefully… Read more»
ial4 replied to the topic "Factors to Consider While making Gantt Chart" – 6 years ago

Hi, To complete a project successfully, you must control a large number of activities ,and ensure that they are completed on schedule. If you miss a deadline or finish a task out of sequence, there could be a knock-on effect… Read more»
ial4 replied to the topic "Design Review Meetings" – 6 years ago

Hi, A design review is a milestone within the product development process whereby a design is evaluated against its requirements in order to verify the outcomes of the previous activity and identify the issue and correct it . There are… Read more»
ial4 replied to the topic "Design Transfer and Challenges" – 6 years ago

Hi, I agree with the above discussion, following are the problem during design transfer. 1. The workflow of the manufacturing organization is disrupted by having to wait for released materials, procedures, and test fixtures. 2.The purchasing department does not have… Read more»
ial4 replied to the topic "What are Design Controls?" – 6 years ago

Hi, Design control are interrelated set of practices and procedures that are incorporated into the design and development process.A design control provides a systematic assessment of the design an integral part of development. As a result ,deficiencies in design input… Read more»
ial4 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" – 6 years ago

Hi, I agree with the above discussion . Design control is required for the EU release product .Actually DHF is used only before product release .Once the product is commercially released ,all changes are under production control and all changes… Read more»
ial4 posted a new topic "What is retention ?" – 6 years ago

The old saying is true: It’s not technology or financial assets that make your business great—it’s your people. You’ll have a critical advantage over your competition if you know how to retain good people. Retention doesn’t mean you try to… Read more»
ial4 posted a new topic "Post-project lessons learned" – 6 years ago

Closing down a project gives team members a chance ti reflect on what they’ve accomplished, what went right, what went wrong, and how the outcome might have been improved.such reflections from the core of the organizational learning-which should be leveraged… Read more»
ial4 posted a new topic "Overlapping activities" – 6 years ago

Hello everyone, Suppose you’re leading a project aimed at updating the packaging for a product line. You begin the planning phase by estimating your project budget and completion date.when you enter the buildup phase ,you get much more specific in… Read more»
ial4 posted a new topic "Mange Project Risks" – 6 years ago

Have you asked all stakeholders to identify potential risks? Project team members, customers, and suppliers will see risk from different perspectives. (for example,a supplier might tell you that a rival company is working on a product for the same market… Read more»
ial4 posted a new topic "Design input sources" – 6 years ago

Hi, Design input are one of the key point in design control.Design inputs mean the physical and performance characteristics of the device that are used as a bases for device design. The main procedures for design input are document ,review… Read more»
ial4 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 7 years ago

As posted above, after graduation everyone need to gain experience and enter into manger role. I am working for a big organization for 6 months now . I also have engineers who is experienced for 25 years. They have all knowledge about the work. But why they are not interested in becoming a manager. I asked one of them, He told its is hard to…[Read more]
ial4 replied to the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial 7 years ago

Project management team can be big and small depends on the organization , project work ,resources, knowledge skill ect. Team can be big or small they ultimate aim is reach project scope and description.
ial4 replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 7 years ago

Project managers have a great role in motivating the tram members. When a leader defines the purpose, vision and value , you articulate a set of principle that focus your efforts and guide you in making choices, interacting with others,and working towards meaningful objectives. Always leaders rely on Management skills, Interpersonal skills,…[Read more]
ial4 started the topic What is retention ? in the forum Project Management Application: Clinical Trial 7 years ago

The old saying is true: It’s not technology or financial assets that make your business great—it’s your people. You’ll have a critical advantage over your competition if you know how to retain good people.
Retention doesn’t mean you try to hang on to every employee forever. Nor does it entail spending time and energy trying to keep employees…[Read more]
ial4 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 7 years ago

Studies says that factor that help retention are Meaningful work, Compensation and pride in the organization. When does it mean by these factor. By having a meaningful work : people stay when their daily work matches their talents and interests, and when they are given opportunities to grow. people are more productive when they are satisfied by…[Read more]
ial4 replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial 7 years ago

Even if your job is challenging , you may quit that job or you may feel demotivated because of lack of appreciation or recognition you get for the work you completed so far. so appreciation has an important role in making employee stay. what make employee leave there job ? that is a important question and i agree with most of the discussions…[Read more]
Load More

@ial4