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Josh posted a new topic "Discussion Topic: Realities of Planned Value" – 4 years, 12 months ago
Keep in mind that in this course we are teaching the ideals of project management in a medical field. This is the best it could ever be, and more than that, this type of project management we are learning here… Read more»
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Josh posted a new topic "Discussion Topic: Design and Process Verification" – 4 years, 12 months ago
When comparing Project Management Processes to Design Controls, I laid out a diagram that synced them up roughly. On that diagram it shows that Verification takes place during the Execution phase of the project. Do you think this is a… Read more»
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Josh posted a new topic "Discussion Topic: The critical path" – 4 years, 12 months ago
Everyone who has worked on a project has a story where a critical path was somehow delayed for varying reasons. As someone working in the hydrophilic coatings industry for a while, I had a lot of customers think of my… Read more»
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Josh posted a new topic "Discussion Topic: Integrating Six Sigma into Project Planning" – 4 years, 12 months ago
In this course we have not discussed other tools such as Six Sigma, but they can nonetheless be important components for project planning.
Explain your thoughts on how a Six Sigma process would integrate with the Project Planning Process.
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Josh posted a new topic "Discussion Topic: What are the PM elements in your company?" – 4 years, 12 months ago
Project Initiation requires several things, as per the lecture, and two of them are enterprise environmental factors and organizational process assets. Give some examples of each as they appear in your organization where you work. How would you mobilize these… Read more»
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Josh posted a new topic "Discussion Topic: State of your Organization" – 4 years, 12 months ago
If you currently work in Industry, tell us what kind of organization you work with, i.e. whether it is a functional, matrix, or project-based one. If you do not work in Industry yet, tell us what kind you feel you… Read more»
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Josh posted a new topic "Discussion Topic: To trial or not to trial" – 4 years, 12 months ago
Take a look at the lecture where it talks about Design Validation. In your words, what is Design Validation? In the following examples, do you think that the device would need a clinical trial as part of Design Validation or… Read more»
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Josh posted a new topic "Discussion Topic: The proper time for Project Initiation" – 4 years, 12 months ago
One of the unsettled discussions in smaller companies especially is when to move on from abstract talk to actual planning and laying out a proposal. Consider a technology like a new biomaterial which may be in development for some time,… Read more»
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Josh posted a new topic "Discussion Topic: GMP's" – 4 years, 12 months ago
Another important aspect which often overlaps with Regulatory: Good Manufacturing Practices (GMP’s) What are GMP’s? Many of you can google things and bring back links, I’m sure, but in practical terms, in real life, they mean several things. 1) Traceability… Read more»
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Josh posted a new topic "Discussion Topic: The 510k Process" – 4 years, 12 months ago
One “fun” thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process. One of the key events in the saga was a controversial report issued by the Institute of… Read more»
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Josh posted a new topic "Discussion Topic: Projects of all types" – 4 years, 12 months ago
How do you think Project Management differs in different industries or different types of Project? If you are a great PM for doing Medical Device Projects, does that mean I can throw you into a software company and have you… Read more»
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Josh posted a new topic "Discussion Topic: Share your project management experience" – 4 years, 12 months ago
Some of you taking this class might work in industry already, and not necessarily in the medical device field either. Whatever industry you work with, share some of your experiences about the following: * What sorts of project management software… Read more»
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Josh posted a new topic "Discussion Topic: Clinical trials around the world" – 4 years, 12 months ago
Describe your thoughts on what regulations or codes each of the following clinical trials would need to comply with: Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe Embolic coil device manufactured in the EU… Read more»
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Josh posted a new topic "Discussion Topic: Vagueness of GMP's" – 4 years, 12 months ago
If you have made it this far in the course, you know that GMP’s must be implemented, but they are not a set list of requirements. Rather, they are a framework with general requirements. Do you think that this ambiguity… Read more»
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Josh posted a new topic "Discussion Topic: When Quality Systems change in the middle of a project" – 4 years, 12 months ago
What happens with projects that are currently being carried out when the Quality System for the company changes drastically? Is there a certain time where a project has just reached a point where it can be considered “grandfathered” into the… Read more»
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Josh posted a new topic "Discussion Topic: Managing the Product Life Cycle" – 4 years, 12 months ago
At each stage of the product life cycle, certain aspects are key. For example, in the early stage, Development, it is important to be compliant with FDA and EU regulations but even before that to have a coherent research method… Read more»
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Josh posted a new topic "Discussion Topic: Playing with IQ, OQ, PQ" – 4 years, 12 months ago
Taking the ISO names for these processes: IQ, OQ, PQ, let’s look at some devices and summarize what kinds of tests or data you would want to collect to complete each of them. In other words, for each process below,… Read more»
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Josh posted a new topic "Discussion Topic: Differences between ISO and FDA" – 4 years, 12 months ago
What are the FDA and ISO saying in reference to process validation where : “inspection” ≈ “monitoring” and “test” ≈ “measurement” Would IS ultimately still require “full” verification for a process that supposedly did not need validation? What are your… Read more»
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Josh posted a new topic "Discussion Topic: Post-market surveillance" – 4 years, 12 months ago
This module discusses many of the contents of the device master record (DMR), and among those contents were the procedures on post-market surveillance. Post market surveillance is becoming an increasingly scrutinized and important component of device development as the FDA… Read more»
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Josh posted a new topic "Discussion Topic: Is the DHF a living document?" – 4 years, 12 months ago
There is some reference to this subject in the modules for this course and the Medical Device Development course. One school of thought says that the DHF is sealed at the end of Design Transfer and never altered again. Any… Read more»
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