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la82 replied to the topic "Making up tests for design verification and validation" – 5 years, 11 months ago
Hello Roberto, I have done some research like my classmates, it was interesting to read that the FDA points out to verification not only in terms of tests. They list guidelines such as analysis and inspections. I agree with my… Read more»
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la82 replied to the topic "Design Review Meetings" – 5 years, 11 months ago
Hi I don’t have an experience with them, but I can imagine if they don’t exist how hard is it to implement a change or realize when a mistake is happening. If you don’t have a review meeting after every… Read more»
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la82 replied to the topic "Minutes for meetings" – 5 years, 11 months ago
Hello Roberto, This question is very interesting. Many people overlook the importance of meeting minutes. Meeting minutes are very crucial to industries such as medical devices. Things like important dates and details that someone might have not heard, or a… Read more»
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la82 replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 11 months ago
You make a great point regarding the dates. Good communications should be kept to makes things move smoothly. Trials as you mentioned is one of the major time consuming factors. If all involved parties are in good synchronization with each… Read more»
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la82 replied to the topic "What are Design Controls?" – 5 years, 11 months ago
thank you for your reply! To clear my statement, I meant that with the long process and amount of time the company needs to invest in the process of design controls and abiding by it, they mostly use it as… Read more»
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la82 replied to the topic "What are Design Controls?" – 5 years, 11 months ago
Design controls are very essential and useful as others have mentioned. They have listed what they are and their benefits, to avoid repetition, I would like to shift the discussion to a key challenge to design control. The process of… Read more»
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la82 posted a new topic "Work Logs and FDA Audits" – 5 years, 11 months ago
Another topic was mentioned about the importance and examples of logging your work throughout a project. In one of the comments someone mentioned that it could get very serious if this information isn’t available when FDA audits the company. Does… Read more»
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la82 posted a new topic "Best timing for validation and verification" – 5 years, 11 months ago
The process of validation and verification is very important in device development. with that being said, when is the best time to carry out these two important steps during the project’s span ?
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la82 posted a new topic "Project Management Preferences" – 5 years, 11 months ago
The lectures introduce the three types of organizations. Project managers’ roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference of working under one or the other, no one mentions what is best for… Read more»
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la82 posted a new topic "The change from ALARP to AFAP" – 5 years, 11 months ago
While researching about one of the discussions posted on the forum about “As far as possible (AFAP)”, I came across the fact that they have changed to this term from ” As low as reasonably practicable (ALARP). I would appreciate… Read more»
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la82 posted a new topic "Consequences Of Insufficient Design Controls" – 5 years, 11 months ago
As mentioned in other discussions, design control is an integral part of any medical device design, and its benefits are clear. However, what are some of the issues that arise of the process and if it is used insufficiently ?… Read more»
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la82 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
These results don’t surprise me at all. The social environment that we surround ourselves with has a huge impact on what we do as individuals. Regardless if it is work, school or anything else where motivation is applicable. If I would categorize myself in one of those categories I would say I am motivated by being recognized/valued & respected.…[Read more]
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la82 replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
I agree with the above comments, the project managers level of motivation spreads through the team. The spirit of motivation is contagious and very helpful. The project manager needs to show interest, passion and motivation to allow others to act as their leader. If a project manager is not motivated, it will have a huge impact on everyone else on…[Read more]
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la82 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
Similar to others, challenge and satisfaction motivate me. The satisfaction of achieving a goal that I have been working toward and challenging myself through the process helps my motivation. For example, for my capstone project, I had to learn an entirely new software language. the challenge that came with this project motivated me to learn and…[Read more]
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la82 replied to the topic Organizational structure in the forum Project Management Knowledge Areas 7 years, 12 months ago
I have had a similar situation to yours where one team member was replaced by multiple. Do you think it is a good practice for companies to hire more than the needed staff by one or two people ?
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la82 replied to the topic Integration PM in the forum Project Management Knowledge Areas 7 years, 12 months ago
For my capstone project, I haven’t had to put the whole entire system together yet, but for two major parts we encountered a lot of problems while putting them together. The project consists of mainly a hardware part and a software part and within the hardware component we needed to integrate a camera with infrared to use the whole system for eye…[Read more]
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la82 replied to the topic Procurement Management in the forum Project Management Knowledge Areas 7 years, 12 months ago
I don’t have any experience of my own, but my father owns a company and procurement is a major key to a company’s success. I agree with bb254. The points she mentioned are major points in procurement management. I would like to add from my father’s experience that having a solid back up plan for vendors is necessary. Things come up with vendors,…[Read more]
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la82 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 8 years ago
An example of a risk I am evaluating right now with my team, is power risk, The device we are working on depends on infrared reflection, and according to the Occupational Safety and Health Administration (OSHA) standards, there is a risk of burning the user’s eye if the emitting power of the infrared is above a certain limit. We are trying to…[Read more]
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la82 replied to the topic FDA Recall…Now What? in the forum Project Management Process and Medical Device Development 8 years ago
I agree with the previous two comments, things like that I didn’t have any knowledge about until this course, it is very important in cases like this to understand which type of change must occur and how that will affect the entire project. As bb254 mentioned, going back to the planning phase will be a necessity and that will put everything else…[Read more]
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la82 replied to the topic Ideal PM Processes vs. Real life in the forum Project Management Process and Medical Device Development 8 years ago
In my opinion, even if the initiating and planning process was extensive and very detailed, there are always some details, risks or problems that were never apparent until you reach the executing phase. In theory things might fit and seem perfectly put together and during the planning phase it is all about theory. It comes down to past experiences…[Read more]
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