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hruship101 replied to the topic "Fitbit: A Medical-Grade Device?" – 5 years, 10 months ago
I agree with most of the participants that fitbit is a device made for consumer use. It is NOT a device that doctors recommend to monitor his or her heart rate and activity. It does not harm or pose a… Read more»
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hruship101 replied to the topic "Ideal project team" – 5 years, 10 months ago
I agree with most of the participants in these posts on what should be an ideal project team consists of. If I were to be a project manager, communication skills is the number one skill I would look for. Also… Read more»
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hruship101 replied to the topic "Product Life Cycle" – 5 years, 10 months ago
I agree with Roberts’s opinion that every product has its Life Cycle in which the product undergoes different phase such as Development, Introduction, Growth, Maturity, and Decline. It all depends on how accurately the product satisfies the customer needs and… Read more»
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hruship101 replied to the topic "Tests for validation and verification phase" – 5 years, 10 months ago
During my experience, I have noticed that most companies have Validation Engineer that performs various tests to validate a machine which is also known as (IQ, OQ, & PQ). There are some specific guidelines set by the FDA that aide… Read more»
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hruship101 replied to the topic "Experience with Design Control" – 5 years, 10 months ago
My experience with design control was with Triangle Manufacturing when I was working as a Quality Engineering co-op. One of my responsibilities was to take part in design meetings and assist the project manager to create BOM (Bill of Materials)…. Read more»
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hruship101 replied to the topic "Mobile Medical Applications" – 5 years, 10 months ago
In my opinion, I believe that your senior design product would be considered as a mobile medical app. In the week 1 lecture, we learned that Medical Device is anything that cure, prevent, or treat disease in humans. Furthermore, your… Read more»
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hruship101 replied to the topic "Meat without Murder" – 5 years, 10 months ago
First of all, thank you djr32 for putting up this article. It’s very interesting to do research in developing artificial organs from the lab grown biological organs. I completely agree with the above posts that artificial organs would be a… Read more»
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hruship101 replied to the topic "Discussion Topic: GMP's" – 5 years, 10 months ago
In today’s world of manufacturing, it is essential for a company to have regulatory laws in place. Good Manufacturing Practises (GMP’s) are regulations placed to meet the company’s quality standards and production standards. More importantly, GMP’s regulation sets the company… Read more»
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hruship101 posted a new topic "Factors to consider when executing the NDA" – 5 years, 10 months ago
How does a company decides how much information is to be disclosed via the NDA agreement? What decision factors and criteria are taken into the consideration by the management team of the company? Please briefly describe your opinion and share… Read more»
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hruship101 posted a new topic "Matrix Organization- Conflict" – 5 years, 10 months ago
One of the type of organization we learned this week is called the Matrix Organization. There are project managers as well as the direct hiring manager working towards the same goal of the project. One of the disadvantages is that… Read more»
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hruship101 posted a new topic "Auditor's view of DHF / DHR" – 5 years, 10 months ago
In the medical device industry, there are various audits that takes place. For example, customer audit, notified body audit from FDA or BSI, and internal audit. If you participated in an audit, briefly describe your experience, and is DHF usually… Read more»
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hruship101 posted a new topic "Design Control Experience" – 5 years, 10 months ago
From this week lecture, we learned what is Design Control and the different phases of Design Control. Please share an experience working with design control in a school project or in an industry. What design control did you take in… Read more»
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hruship101 posted a new topic "Clinical Trial Experiment" – 5 years, 10 months ago
In Undergraduate Biomedical Engineering Curriculum at NJIT, students are required to take the Capstone (Senior Design Project) Class. If the project involves testing on human subject, an IRB approval is required prior to conducting the experiment. I feel like we… Read more»
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hruship101 posted a new topic "What are some ways Document Control can improve?" – 5 years, 10 months ago
Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the lot to be… Read more»
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hruship101 posted a new topic "Changes in FDA under Trump's Administration" – 5 years, 10 months ago
What do you think of the new Trump’s 2018 budget proposal of $2 billion increase in FDA User Fees for medical device registrants for 2018? Will this have an impact on the use of de novo 510k Process? Please share… Read more»
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hruship101 posted a new topic "Milestones Missed: Failure or Success?" – 5 years, 10 months ago
During a project, we set milestones to achieve. However, due to certain circumstances, we cannot meet the deadline that results in missing a milestone. Missing a milestone can be either a failure by the team or it makes the overall… Read more»
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hruship101 started the topic Factors to consider when executing the NDA in the forum Consultants and Legal Basics 7 years, 4 months ago
How does a company decides how much information is to be disclosed via the NDA agreement? What decision factors and criteria are taken into the consideration by the management team of the company?
Please briefly describe your opinion and share an experience of executing the NDA.
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hruship101 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 7 years, 4 months ago
This is a really interesting topic to discuss. There are many pros and cons of having a written agreement versus verbal agreement. Many medical device companies execute a supplier quality agreement with the suppliers on their approved supplier list (ASL). This is a legal written agreement detailing the terms and conditions of the customer to…[Read more]
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hruship101 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 7 years, 4 months ago
I agree with all of the participants in this post regarding Dr. Simon’s class. This is my second semester as Masters in Biomedical Engineering and also second time taking a class with Dr. Simon. Previous semester, in project management class, I’ve learned a lot in terms of FDA regulations and project management. During this course, it was mor…[Read more]
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hruship101 started the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies 7 years, 4 months ago
One of the type of organization we learned this week is called the Matrix Organization. There are project managers as well as the direct hiring manager working towards the same goal of the project. One of the disadvantages is that team involved in the project has two (or more) bosses.
There are many students who currently works in a Matrix…[Read more]
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