https://medicaldevicecourses.com/members/lianhuajin/activity/ Activity feed for lianhuajin. Fri, 24 Apr 2026 22:30:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3889b802ea14f0a805399b8724793a11 https://medicaldevicecourses.com/activity/p/14491/ Wed, 15 May 2019 18:57:24 -0400 While a patent is a federal document providing ownership of an idea, NDA which is non disclosure agreement is just a simply contract between two people. NDA can provide people with a level of protection and NDA is not as…   Read more»

]]> 0e86bc1c6e833894a44f77e0d055c0d4 https://medicaldevicecourses.com/activity/p/14490/ Wed, 15 May 2019 18:57:23 -0400 I think I am very lucky to take this course before I graduate. I always hope that I can learn some information about medical device company before finding job since Lack of knowledge in the industry always make me nervous….   Read more»

]]> 52c34b57a4ca35f8f4fc79c5fcecda27 https://medicaldevicecourses.com/activity/p/14489/ Wed, 15 May 2019 18:57:23 -0400 Generally speaking, most contacts can be either written or oral and legally enforceable, however there are several types of agreements which have to be in writing. I listed them below. 1. Real estate sales 2. Agreements to pay someone else’s…   Read more»

]]> 35897a65896c44e10de08f5ef7cb1c12 https://medicaldevicecourses.com/activity/p/14230/ Wed, 15 May 2019 18:54:15 -0400 If I were to start up a medical device company, I will choose matrix type organization. One of the reasons is that because the matrix structure is more dynamic because it allows employees to communicate more readily across the boundaries,…   Read more»

]]> ad0e4a66762ba79abbdf4323ce7a54c4 https://medicaldevicecourses.com/activity/p/14229/ Wed, 15 May 2019 18:54:15 -0400 I would like to work in matrix type organization. As mentioned in the video, the matrix organization structure is a combination of two or more types of organizational structures, such as the projectized organization structure and the functional organization structure.This…   Read more»

]]> ee9afacc7899896c0ade465bd3045e97 https://medicaldevicecourses.com/activity/p/14228/ Wed, 15 May 2019 18:54:14 -0400 I found a few tips for avoiding dysfunction of team project on the internet. 1. Size, Go with smaller teams—the bare minimum necessary to get the work done. The typical project team size is five to nine members. If you…   Read more»

]]> 081769c8776c425f2512ec8aed1aa5c8 https://medicaldevicecourses.com/activity/p/14222/ Wed, 15 May 2019 18:53:09 -0400 I do not have experience. But I searched about it online and found that for risk identification, the project team should review the program scope, cost estimates, schedule (to include evaluation of the critical path), technical maturity, key performance parameters,…   Read more»

]]> 3796f9b80a1a8d1f80bc509a11786dd1 https://medicaldevicecourses.com/activity/p/14221/ Wed, 15 May 2019 18:53:08 -0400 I found that the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration in higher regard than of the requirements of safety and performance of medical devices. Contradicting this approach, AFAP requires that all ventures of…   Read more»

]]> afba90a5635191e1d1666d2a6ff596c9 https://medicaldevicecourses.com/activity/p/14210/ Wed, 15 May 2019 18:53:03 -0400 The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body function. By contrast, pharmaceuticals are medicines, designed to engage the body’s chemistry….   Read more»

]]> 1ee02a3ec9caa1e8b5559876f39acffc https://medicaldevicecourses.com/activity/p/14066/ Wed, 15 May 2019 18:51:36 -0400 I will mainly talk about customer input sources. Every organization actually has two different types of customers: Internal Customers and External Customers.Most people are familiar with their external customers – these are your end users and even your intermediate users…   Read more»

]]> 607c04d5deee2f1e70432f1dfe71e2fb https://medicaldevicecourses.com/activity/p/14064/ Wed, 15 May 2019 18:51:35 -0400 I have less experience on writing protocols but I searched about this online and found that sample sizes are calculated based on the magnitude of effect that the researcher would like to see in his treatment population (compared with placebo)….   Read more»

]]> aee865e374ca715349aa1dbe028949f2 https://medicaldevicecourses.com/activity/p/14046/ Wed, 15 May 2019 18:51:24 -0400 I searched about the Korean Regulatory System The Ministry of Health and Welfare (MHW) is the primary healthcare agency regulating the importation of medical devices. Under Korea’s Medical Devices Act, the Korea Food and Drug Administration (KFDA), an agency under…   Read more»

]]> ca4a168452beca02f97071d7d55eccc5 https://medicaldevicecourses.com/activity/p/13862/ Wed, 15 May 2019 17:08:54 -0400 Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate you have designed and developed a medical device that meets user needs, is safe and effective. The relationship between Design Controls…   Read more»

]]> 0131c4eb9ddd4a1c414b081ffb0b2596 https://medicaldevicecourses.com/activity/p/13861/ Wed, 15 May 2019 17:08:53 -0400 In my opinion, the most important phase is scope management plan. scope management plan is the collection of processes used to ensure that the project includes all the tasks required to complete the project while excluding all work which is…   Read more»

]]> 6a2c738a012e6b2355b634738178ecb4 https://medicaldevicecourses.com/activity/p/13857/ Wed, 15 May 2019 17:08:51 -0400 I think insufficient design control would, firstly, waste money and energy, since engineers spent time and money on useless design. It is also kind of financial loss for the company. Moreover. It is also damage the image of company if…   Read more»

]]> 71ef579adc0ff962d491a8159e152e25 https://medicaldevicecourses.com/activity/p/13784/ Wed, 15 May 2019 17:08:10 -0400 I‘d like to play a role of investigator，since I love research. I’d love to study whether the drug I am working on is safety when people taking it. This role is very important because investigators should be responsible for the…   Read more»

]]> dd33b94964c661f6a67ac600d3aae95f https://medicaldevicecourses.com/activity/p/13782/ Wed, 15 May 2019 17:08:09 -0400 I think double blind test is better. Since some scientists are dishonest, they often have pressures comes from billion dollar drug companies and the fight of research grants, so they want to have positive results. Therefore they may give the…   Read more»

]]> 4b02e8b93b1d820b9a9fee8b183b4622 https://medicaldevicecourses.com/activity/p/13780/ Wed, 15 May 2019 17:08:08 -0400 Clinical trials are risky, but I do not agree to inhibit doing clinical trials, since it is very important for research. In my opinion, a strategy should be required for reducing the risk comes from clinical trials. For example, participants…   Read more»

]]> 817a533137fe092c49d74f00548dca9b https://medicaldevicecourses.com/activity/p/13580/ Wed, 15 May 2019 17:06:14 -0400 I select a company that design ophthalmological surgical tools, the name is NovOculi. NovOculi employs a method involving iontophoresis, an ionic dye, and a wavelength-specific laser to accomplish effective refraction without the troublesome destruction of epithelium. Strengths Patented technology: they…   Read more»

]]> 00e14c7a777a58d42a1f43d93f4d77bf https://medicaldevicecourses.com/activity/p/13576/ Wed, 15 May 2019 17:06:12 -0400 There is a pretty clever way of marketing i met before, that is drawing a lottery and introduce the products as a prize. I agree with that using social media is a good way of marketing, but actually some medical…   Read more»

]]> 41f3cd2903bb3622d17e40773ed3eff9 https://medicaldevicecourses.com/activity/p/13571/ Wed, 15 May 2019 17:06:10 -0400 Emotional intelligence is the ability to identify and manage your own emotions and the emotions of others. I think highly of EI. People’s emotions plays a important role on the efficiency of work. For example, If you have bad mood,…   Read more»

]]> 361e23236002fb39d7bb66c280f76a30 https://medicaldevicecourses.com/activity/p/13418/ Wed, 15 May 2019 17:04:43 -0400 when court will pierce the corporate veil? I googled it and Courts might pierce the corporate veil when all of the following are true. Firstly, there is no real separation between the company and its owners. If the owners fail…   Read more»

]]> 8a26330f8d82a75fcd15bbaade493c78 https://medicaldevicecourses.com/activity/p/13406/ Wed, 15 May 2019 17:04:38 -0400 A public corporation is a business whose securities are traded on the public stock exchanges. A private company is held solely by its owners and is not traded publicly. A big difference between private and public companies involves public disclosure….   Read more»

]]> 014a799e28851fa6c25cc6fb39e4f9db https://medicaldevicecourses.com/activity/p/13400/ Wed, 15 May 2019 17:04:35 -0400 I would want to be an owner of LLC in the US because of these benefits. First of all, there is no residency required, owners of an LLC do not have to be U.S. citizens or permanent residents. I am…   Read more»

]]> dc44955858bc4424dd5566422663b59a https://medicaldevicecourses.com/activity/p/13347/ Wed, 15 May 2019 17:04:10 -0400 I searched about this title and found that there is the potential for misalignment and conflict when the quality function and the R&D function are divided in two separate organizations, often with different objectives and performance measures. The danger comes…   Read more»

]]> 3ffdff133103514e3967b73971d1dea5 https://medicaldevicecourses.com/activity/p/13334/ Wed, 15 May 2019 17:04:04 -0400 The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s) I found the types of CGMP Drug Inspections online. • Surveillance Inspections – Risk-based frequency – Sites selected by risk model…   Read more»

]]> 041667cfce05e0a9ccf60509dbf87ae6 https://medicaldevicecourses.com/activity/p/13333/ Wed, 15 May 2019 17:04:04 -0400 I will talk one way I think can improve document control. That is promoting training and documentation. Every employee charged with handling some form of document should be trained in content management and proper handling policies as determined by credit…   Read more»

]]> e08070f033614b45c222a81f2b213ff2 https://medicaldevicecourses.com/activity/p/13184/ Wed, 15 May 2019 17:02:42 -0400 I searched about the app for measuring blood glucose. Philosys, secured approval from the U.S. Food and Drug Administration for a portable blood glucose meter that hooks into Android devices through the headphone jack. It had previously received 510(k) clearance…   Read more»

]]> aaecb0474175cb4bc87be6ad4a7716d1 https://medicaldevicecourses.com/activity/p/13182/ Wed, 15 May 2019 17:02:41 -0400 “De Novo” pathway- Established by the Food and Drug Administration Modernization Act of 1997 to provide a new mechanism for reclassification of certain lower risk devices from class Ⅲ to class ⅠorⅡ. Examples of De Novos Granted for Devices Presentng…   Read more»

]]> 5b29216b1ebf615d13d588d64afc2f37 https://medicaldevicecourses.com/activity/p/13165/ Wed, 15 May 2019 17:02:32 -0400 I saw an interesting news about e-cigarette that teens actually using e-cigarette more than tobacco cigarette. and the trend is growing. And the Center of the Disease says now teens using vaporizers three times more than they did in the…   Read more»

]]> ff1c2a6149c3be1b2f0df5563fede0ce https://medicaldevicecourses.com/activity/p/13155/ Wed, 15 May 2019 17:02:27 -0400 Doing a research by using animal model may be cruel, but we do not have other options which are better than this one. Maybe in the future, people can make some biological robot which can be used in the biology…   Read more»

]]> e1a21c297c144170d2e4eeed62e42d4a https://medicaldevicecourses.com/activity/p/13154/ Wed, 15 May 2019 17:02:27 -0400 I had no opportunity to do industry research, but I can feel that money is the most important thing that people care about in the industry research.When I worked in academia research, I found that people more care about having…   Read more»

]]> fa294eb7210e116136d708fac6199ec1 https://medicaldevicecourses.com/activity/p/13146/ Wed, 15 May 2019 17:02:23 -0400 I prefer doing research which can help present generation, since it can not make sure what is going to happen to next generation。 If we can’t solve the problems for present generation, the problems would pass down to the next…   Read more»

]]> fa3e221c30966e08245dc38396eb045a https://medicaldevicecourses.com/activity/p/13122/ Wed, 15 May 2019 17:02:07 -0400 The obstacle I met when I was working on a project was the discrepancy between the members. It is very usual that one group of members have more than one opinion on the same things. And everyone think their opinions…   Read more»

]]> c7f7d2827f4a13363d2aac6e444c6c0d https://medicaldevicecourses.com/activity/p/13121/ Wed, 15 May 2019 17:02:07 -0400 I think the most important phase is planning phase since a plan can decide many things. Good plan can save time, save budget and also save energy. If you have good plan, your project is more likely to success. Also…   Read more»

]]> 8c223e23b1d0ce94a24c0c6e6a3885d8 https://medicaldevicecourses.com/activity/p/13117/ Wed, 15 May 2019 17:02:05 -0400 In my opinion, Manager does not need to have more knowledge than their members. I met a few managers before, they do not know more than their members, they can be the manager of the team may be because they…   Read more»

]]> a875086714b3e98377016de00834073a https://medicaldevicecourses.com/activity/p/13109/ Wed, 15 May 2019 17:02:01 -0400 I think both are important, but, in fact, there is limited practical courses in the school, and I do not know why? We learn engineering and in this area, I think, problems always come from practice or not papers. Sometimes…   Read more»

]]> 3877ccb8e2076ca139b75cd68db5c4cb https://medicaldevicecourses.com/activity/p/13106/ Wed, 15 May 2019 17:02:00 -0400 I prefer industry over academia, as I learned in the course, we can earn more money from industry. Besides, industry is about marketing and I love marketing. But I feel that industry requires more from their employee. I saw many…   Read more»

]]> 8623cbfba7a4418366336a8f7efa5b68 https://medicaldevicecourses.com/activity/p/13105/ Wed, 15 May 2019 17:01:59 -0400 Yes. Do an internship is very important. Since we spent so much time in the school, and what school can give us is limited. We need other way to learn something that we can not learn from school and in…   Read more»

]]> cd24cf9c7daeebb0401eae67eb15e4cc https://medicaldevicecourses.com/activity/p/5545/ Mon, 04 Dec 2017 20:21:10 -0500 While a patent is a federal document providing ownership of an idea, NDA which is non disclosure agreement is just a simply contract between two people. NDA can provide people with a level of protection and NDA is not as powerful as patent since it provides no protection against independent creation by ohters, or even the disclosure organization…[Read more]

]]> 0 9ee23d6dbcf69b7fbb8f62aff865922d https://medicaldevicecourses.com/activity/p/5544/ Mon, 04 Dec 2017 19:59:48 -0500 I think I am very lucky to take this course before I graduate. I always hope that I can learn some information about medical device company before finding job since Lack of knowledge in the industry always make me nervous. After I take this course, I learned that working in the medical device company, just like what I thought before, is…[Read more]

]]> 0 cb92601cb6f4b657d79168d78bb946a7 https://medicaldevicecourses.com/activity/p/5543/ Mon, 04 Dec 2017 19:35:27 -0500 Generally speaking, most contacts can be either written or oral and legally enforceable, however there are several types of agreements which have to be in writing. I listed them below.
1. Real estate sales
2. Agreements to pay someone else’s debts
3. Contracts that take longer than one year to complete
4. Real estate leases for longer than one…[Read more]

]]> 0 c0978e9f3878a5adabdb1450424e3164 https://medicaldevicecourses.com/activity/p/5266/ Thu, 23 Nov 2017 21:04:17 -0500 If I were to start up a medical device company, I will choose matrix type organization. One of the reasons is that because the matrix structure is more dynamic because it allows employees to communicate more readily across the boundaries, creating a good, cooperative, work environment which helps to integrate the organization. Moreover,employees…[Read more]

]]> 0 8c6a68c2d9255f312f71395a04fb7497 https://medicaldevicecourses.com/activity/p/5265/ Thu, 23 Nov 2017 20:58:43 -0500 I would like to work in matrix type organization. As mentioned in the video, the matrix organization structure is a combination of two or more types of organizational structures, such as the projectized organization structure and the functional organization structure.This combination may help organizations achieve higher efficiency, readiness, and…[Read more]

]]> 0 fae405f4b20fdabf1563c292a8c5988d https://medicaldevicecourses.com/activity/p/5264/ Thu, 23 Nov 2017 20:32:41 -0500 I found a few tips for avoiding dysfunction of team project on the internet.
1. Size, Go with smaller teams—the bare minimum necessary to get the work done. The typical project team size is five to nine members. If you assign more people than needed, just to be safe, you might experience Parkinson’s law: Work expands to fill the time available for…[Read more]

]]> 0 fc568ada1e65cfc83ab034709bce5a99 https://medicaldevicecourses.com/activity/p/5257/ Wed, 22 Nov 2017 04:05:00 -0500 I do not have experience. But I searched about it online and found that for risk identification, the project team should review the program scope, cost estimates, schedule (to include evaluation of the critical path), technical maturity, key performance parameters, performance challenges, stakeholder expectations vs. current plan, external and…[Read more]

]]> 0 f1a2bce973c9f3b9a0b55d6cb24a9226 https://medicaldevicecourses.com/activity/p/5256/ Wed, 22 Nov 2017 03:52:38 -0500 I found that the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration in higher regard than of the requirements of safety and performance of medical devices. Contradicting this approach, AFAP requires that all ventures of safety must be addressed in the intent of the consumer and effectiveness…[Read more]

]]> 0 cf0ccf529c11c1dbd9e673bf89160954 https://medicaldevicecourses.com/activity/p/5245/ Tue, 21 Nov 2017 06:14:54 -0500 The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body function. By contrast, pharmaceuticals are medicines, designed to engage the body’s chemistry. Secondly, Medical devices have different efficacy d…[Read more]

]]> 0 1a37f5ae49820111d81c4f4c0c883c4e https://medicaldevicecourses.com/activity/p/5089/ Mon, 13 Nov 2017 04:58:26 -0500 I will mainly talk about customer input sources. Every organization actually has two different types of customers: Internal Customers and External Customers.Most people are familiar with their external customers – these are your end users and even your intermediate users (dealers, distributors, brokers, etc).
If you’re in a regulated industry (an…[Read more]

]]> 0 950674da33d9a127553a9038bb819c66 https://medicaldevicecourses.com/activity/p/5087/ Mon, 13 Nov 2017 04:47:01 -0500 I have less experience on writing protocols but I searched about this online and found that sample sizes are calculated based on the magnitude of effect that the researcher would like to see in his treatment population (compared with placebo). It is important to note variables such as prevalence, expected confidence level and expected treatment…[Read more]

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