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andria93 replied to the topic "Engineering change order" – 5 years, 10 months ago
An engineering change order is very important to keep track of any change to the initial proposal and product part especially when you don’t have a locked BOM list. sometimes your dependant on parts suppliers roadmap and end off live… Read more»
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andria93 replied to the topic "Risk Management" – 5 years, 10 months ago
As it was mentioned in the lecture of this week, Risk management sometimes takes place after the deployment of the product. As a field application engineer, we write a FAR report based on eight disciplines problem-solving. D5, D6, and D7… Read more»
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andria93 replied to the topic "''Quality Plan'' meaning ?" – 5 years, 10 months ago
I think quality control plays a big role for the project. Quality control set the expectation of requirement before the project goes to mass production. I believe many companies may do the same product. However what differentiates one from the… Read more»
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andria93 replied to the topic "Funding in Medical Devices Industry" – 5 years, 10 months ago
sadly to say that But you may have the greatest idea but if the companies think it’s not going to bring enough revenue they may turn the project down. you need to know how to market your idea to attract… Read more»
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andria93 replied to the topic "Categorization of Medical Devices" – 5 years, 10 months ago
I think every company is different when it come to categorized ther product but, most of them they will have a focused vertical or sector. each vertical will have it’s series with different version. so for each sector there is… Read more»
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andria93 replied to the topic "Initiating a Project Idea" – 5 years, 10 months ago
I think it’s harder stage because trying to sell just an idea or have others supporting it is not easy compared to a finalized product. it’s harder to market an idea rather than a working finalized product in hand. As… Read more»
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andria93 replied to the topic "Project management team" – 5 years, 10 months ago
I agree with you, choosing the right team member for a project is a big factor in the success. In my past job, we used to work in a group called Solution team in general. Some of us were more… Read more»
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andria93 replied to the topic "Does Product Classification also depend on the Material of the Product used?" – 5 years, 10 months ago
From my experince with Innodisk, A lot of our customers from Medical sector tent to request a locked bill of materials after the FDA approval. Eventhough simillar components will do the same functionality. but they have different tolerence. non of… Read more»
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andria93 replied to the topic "FDA Regulations of Medical Device-Drug" – 5 years, 10 months ago
From my work experience with Panasonic. I had a chance to work a 3D Anatomy project. Th main purpose of the project is education. It is a simulation software for the anatomy of the body and allows you to dive… Read more»
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andria93 replied to the topic "FDA about upgraded device" – 5 years, 10 months ago
I think it depends on what type of upgrade you are looking for. From my work experience with Innodisk which is a company manufacture SSD and DRAM. One of the vertical we focus on is a medical market, and one… Read more»
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andria93 replied to the topic "Fitbit Medical Device?" – 5 years, 10 months ago
I think the Fitbit should be classified as a class 1 device. some of this devices still had sensors to collect health-related information such as; heart rate and blood pressure. Which full under general control. But, I think they classified… Read more»
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andria93 replied to the topic "Determining project priority" – 5 years, 10 months ago
I think you bring up a very valed point. I have seen great project that didn’t continue or been cancelled by the company due to other periority projects. How ever this periority project sometimes is not the best and may… Read more»
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andria93 replied to the topic "Interpersonal skills vs technical knowledge" – 5 years, 10 months ago
I agree with you that based on the course and the article you posted the ratio of interpersonal skills vs technical knowledge is almost 3:1. But, this is the case here as we enrolled in an engineering degree. So, of… Read more»
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andria93 replied to the topic "Discussion Topic: Share your project management experience" – 5 years, 10 months ago
I worked at Panasonic innovation center for two and half years as a solution engineer. we have a dedicated team of program managers and focused project manager. Our C-levels and upper management will set the strategies and tactics for the… Read more»
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andria93 replied to the topic "Simulations" – 5 years, 10 months ago
I would agree with you that face to face meeting is more productive and effective when it comes to time management and quick respond. However, Form my work experience. It is always hard to schedule a meeting that can fit… Read more»
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andria93 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 6 years, 4 months ago
I agree with most of your point, and I think not only with the contractor but even sometimes with internal department and even members from the same team. You need a kind of documentation and often it is hard to document or prove a verbal agreement. Written agreement always a good option to protect your self as well. I had experience that some of…[Read more]
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andria93 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics 6 years, 4 months ago
As you all mentioned above the main difference between Patent and NDA, That Patent protects your ownership of the idea not only on a project base but all over that no one can duplicate or claim your idea. also, you can collect money from companies want to integrate the idea in their design. for example, my current company is the one who designed…[Read more]
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andria93 replied to the topic Advice before signing an NDA in the forum Consultants and Legal Basics 6 years, 4 months ago
I do agree with all your point mentioned above, However, from my current experience with my current company, I do deal with a lot of NDA since I help our customer to spec in our product in their design. They need to protect themselves before sending a sample system, system schematics, etc. However we don’t sign it our self, Our legal department…[Read more]
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andria93 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 6 years, 4 months ago
I do agree with you that you need to gain the experience and take it to step by step. Leadership is one of the main important points for management but, being a good leadership only does not qualify you to be a manager. A lot of people think it is easy to do but it is not. In my industry, I have seen a lot of managers that they are great in one…[Read more]
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andria93 replied to the topic Medical Device Project in the forum Organizational Development in Device Companies 6 years, 4 months ago
The first thing our team did with the help of PM coordination, we created a group chat that we can communicate effectively and have every member on the same page. Also, we created a shared folder so all of us can review and see the documents from other departments. the benefit of it is that to make sure the project is going as scheduled for and…[Read more]
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