Activity | ap962 | Medical Device Courses

ap962 replied to the topic "How to initiate project successfully" – 5 years, 10 months ago

According to me, the first, and most critical, step to initiate a project is defining the extent of the project. What is it you should achieve or make? What is the task objective? Similarly important is defining what is excluded… Read more»
ap962 replied to the topic "Does Product Classification also depend on the Material of the Product used?" – 5 years, 10 months ago

I agree with all the comments made here, and would like to add mah52’s plastic syringe example that as plastic is chemically inert, use of a different grade plastic material would not require a PMA. Also the syringe wouldn’t be… Read more»
ap962 replied to the topic "Initiating a Project Idea" – 5 years, 10 months ago

We’re full of ideas of what would make the best business plan and are convinced that it will earn us plenty of money. To convert these ideas into words and convince investors to see the success of this idea as… Read more»
ap962 replied to the topic "Pros and Cons of the 3 Organizational Structures" – 5 years, 10 months ago

I would like to work in a matrix based organization. I agree with the points made by smitshah and srg36. I would like to add this type of organization will result in good management of resources, it encourages people from… Read more»
ap962 replied to the topic "FDA Regulations of Medical Device-Drug" – 5 years, 10 months ago

The Food and Drug Administration (FDA) is amending its combination product regulations to define “mode of action” (MOA) and “primary mode of action” (PMOA). Where, MOA is the means by which a therapeutic product achieves an intended effect or action…. Read more»
ap962 replied to the topic "Challenges in the Global Regulatory Environment" – 5 years, 10 months ago

I took Dr Collins class “Biomaterials” last spring, and this discussion took me back to a discussion we had in class about the Global Regulatory Environment. The FDA has very stringent rules, that they are adamant into applying. Whereas other… Read more»
ap962 replied to the topic "Fitbit Medical Device?" – 5 years, 10 months ago

In my opinion the Fitbit should be classified as a Class 1 device as similar device exist in the market. This will help decrease the testing period as their are similar devices that prove that such devices are safe and… Read more»
ap962 replied to the topic "Discussion Topic: State of your Organization" – 5 years, 10 months ago

During my internship in the Saad Research and Development center, I worked in a Matrix based industry. There were two organizations locally and two internationally that were funding the research that were going on in the center. From this experience… Read more»
ap962 replied to the topic "Ideal project team" – 5 years, 10 months ago

I agree with the baseline points that everyone has made that a good team compromises of individuals with good communication, are hard working and have a knowledge of the problem. These are some qualities that you would find in any… Read more»
ap962 replied to the topic "Interpersonal skills vs technical knowledge" – 5 years, 10 months ago

As much as I agree with everyone about the importance of technical skills, it’s important to note that employers prefer to train people they bring into work so that they are able to deliver what’s expected of them perfectly and… Read more»
ap962 posted a new topic "Closing Phase" – 5 years, 10 months ago

The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively?
ap962 posted a new topic "Project Execution" – 5 years, 10 months ago

This weeks lecture talks about project planning and execution. As a Project Manager, what are the key factors that need to be taken into consideration for a successful project execution?
Also, what factors you would as a Manager emphasize on?
ap962 posted a new topic "Unapproved Device" – 5 years, 10 months ago

As well know, all medical devices require approval so that they can be used. What do you think happens in the case of an emergency? Can a physician use an unapproved device, if it has the potential to cure a… Read more»
ap962 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I enjoyed reading all the comments in the post and was pleasantly surprised to see how similar the views of everyone here are to the consensus posted in the question. I too would personally agree with the overall results of the study. Money is one of the driving forces for us to work hard and be successful so that we can provide a comfortable,…[Read more]
ap962 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

To ensure a good relationship with vendors we need to keep the following points in mind:
1. Explain your business goals making sure the vendor understands your vision.
2. Pay your bills on time.
3. Assign a dedicated vendor manager.
4. Find out what the vendor needs from you.
5. When mistakes happen, don’t point fingers.
6. Refer a trusted v…[Read more]
ap962 replied to the topic Clinical Project Team Roles in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I would like to work in the Regulatory department if I was part of a clinical project team. Being someone who is always thorough with every step she takes, always planning two steps ahead and always ready with a plan B, the regulatory department would be an ideal fit for me.
ap962 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I would like continue being an engineer. I would like to find my area of interest, build my expertise over the years and a reputation in the industry. Once, I’m at the senior, expert level, I would like move ahead and become a consultant.
ap962 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

What motivates me to work the hardest and put my best foot forward is my desire to learn new things. I work the hardest on a project and like doing everything from scratch because I love how much I learn along the way. The success that comes along with that gives me a sense of independence and accomplishment. Every little win counts toward…[Read more]
ap962 replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas 6 years, 11 months ago

The Six Sigma methodology DMAIC (Define, Measure, Analyze, Improve, Control) offers a structured and disciplined process for solving business problems. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an organization from providing its customers with the consistent quality of products the customers…[Read more]
ap962 replied to the topic Designing effective Communication management Plan in the forum Project Management Knowledge Areas 6 years, 11 months ago

I agree that there should be a common communication management plan that is included as the SOP. This assists in the effective dissemination of information.The information distribution can be designed in compatibility to the project organization chart ensure easy flow of information. Having a common communication plan will also ensure that…[Read more]
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