https://medicaldevicecourses.com/members/hv42/activity/ Activity feed for hv42. Fri, 24 Apr 2026 22:30:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7b41e7d04bf45e02e78f048c33f2fb58 https://medicaldevicecourses.com/activity/p/14441/ Wed, 15 May 2019 18:56:59 -0400 I really like this course, it gives you good industrial insights on a structural manner. I think this course help me to Identify the suitable job profile, now I clearly know I am not a academia person and I am…   Read more»

]]> 8f73354365e666626355580842036988 https://medicaldevicecourses.com/activity/p/14397/ Wed, 15 May 2019 18:55:45 -0400 NDA is a contract, and contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state. Our firm practices patent law, which is federal,…   Read more»

]]> c8c07e0cb3fc7995eedd63b445d8dc15 https://medicaldevicecourses.com/activity/p/14396/ Wed, 15 May 2019 18:55:45 -0400 I don’t think this is to restricted, it should be this way. I will say companies should not even pay $100 because even doctor is also is making enough money by doing the surgery and if the the doctors want…   Read more»

]]> 281b12f40986c5017448a03bf83ef655 https://medicaldevicecourses.com/activity/p/14251/ Wed, 15 May 2019 18:54:26 -0400 I would like to work in Process-based organizational structures, because it is designed around the end-to-end flow of different processes, such as Research & Development, Customer Acquisition, and Order Fulfillment. Unlike a strictly functional structure, a process-based structure considers not…   Read more»

]]> d5f0c335b3e5a6cda95c4126b222f03c https://medicaldevicecourses.com/activity/p/14250/ Wed, 15 May 2019 18:54:26 -0400 In my opinion the best and most effective organizational structure is Circular Organizational structure the circular structure still relies on hierarchy, with higher-level employees occupying the inner rings of the circle and lower-level employees occupying the outer rings.What I mean…   Read more»

]]> 5ea280b26a67804d97e28412f0543bf2 https://medicaldevicecourses.com/activity/p/14249/ Wed, 15 May 2019 18:54:25 -0400 I would say I want people in my team who have more knowledge in their department, because we are working on a project and we want what is best for the project. Sometimes working with people we have better relationship…   Read more»

]]> f77362889418de4135205e92cee83892 https://medicaldevicecourses.com/activity/p/14185/ Wed, 15 May 2019 18:52:50 -0400 ISO 31000:2009 provides principles and generic guidelines on risk management. ISO 31000:2009 can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services and assets….   Read more»

]]> 7a2413ce9cd122f55c8defbad2dd0492 https://medicaldevicecourses.com/activity/p/14184/ Wed, 15 May 2019 18:52:49 -0400 From low severity and for high severity of risk:- 1) Accept The Risk:- This is a good strategy to use for very small risks – risks that won’t have much of an impact on your project if they happen and…   Read more»

]]> 026d986f07003ff1e56a6f4234052c38 https://medicaldevicecourses.com/activity/p/14183/ Wed, 15 May 2019 18:52:49 -0400 1) FORGETTING ABOUT THE USER:- Companies usually forget the main reason why they are developing a product. Failing to include the user in the process often starts right at the beginning of the development process, Ideally, you want to have…   Read more»

]]> 72aa4516161d2b1c09373c000b43e852 https://medicaldevicecourses.com/activity/p/14009/ Wed, 15 May 2019 17:10:23 -0400 I will say the coin has two sides to it so in the same way the outsourcing also has its own advantages and disadvantages, In this case particularly I will say outsourcing is the best option because:- 1- Most of…   Read more»

]]> dd727792de1370101c1ced568db2cb44 https://medicaldevicecourses.com/activity/p/14007/ Wed, 15 May 2019 17:10:22 -0400 I don’t have any experience in the industry, But I have similar experience in my senior year of Undergrad. In capstone class we have the status meeting every week with our professor and our adviser where the professor is our…   Read more»

]]> 5347e22581a841ecd483aa2f83799aa7 https://medicaldevicecourses.com/activity/p/14006/ Wed, 15 May 2019 17:10:21 -0400 I don’t have any industry experience in writing protocols but I have worked in the laboratory where I have done this, and for our study we have used the Gpower analysis. And based on that we decide how many subject…   Read more»

]]> 71ffdffe539b33ac4e893c89afcdcf7f https://medicaldevicecourses.com/activity/p/13844/ Wed, 15 May 2019 17:08:44 -0400 Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from…   Read more»

]]> 9e179518c1e9410141a276cac1617cf7 https://medicaldevicecourses.com/activity/p/13841/ Wed, 15 May 2019 17:08:42 -0400 I am in capstone 2 right now and I will say it is the best class in the entire curriculum we have at NJIT it gives you the idea that how you will be working in the Industry, it teaches…   Read more»

]]> 615a3b13098f1b5b88119afc5e18f946 https://medicaldevicecourses.com/activity/p/13840/ Wed, 15 May 2019 17:08:42 -0400 Government agencies responsible for regulating Medical Devices in India. 1. The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices. 2. The Drug Controller General of India (DCGI) is the key official within…   Read more»

]]> 867b09f3fca05bd9f5397af766b4ee20 https://medicaldevicecourses.com/activity/p/13834/ Wed, 15 May 2019 17:08:39 -0400 Design control is not required in EU, but I would say it is very helpful to have it, EU do have the Design Dossier/ Technical Files which king off go along with Design Control but it is not the same…   Read more»

]]> b5ae0937680fe44e8ce4c74be066e343 https://medicaldevicecourses.com/activity/p/13735/ Wed, 15 May 2019 17:07:46 -0400 Every Coin has two sides of it in the same way every clinical trials has advantages and disadvantages:- Advantages :- 1. You may gain access during and after the clinical trial to new treatments that are not yet available to…   Read more»

]]> 4b19fc228a88b64f85db530839751caf https://medicaldevicecourses.com/activity/p/13733/ Wed, 15 May 2019 17:07:44 -0400 I am currently doing capstone 2 at NJIT, we definitely do the testing of our design but we do not make the clinical trial Protocol. My project is to make the control cortical Impact device which is used to make…   Read more»

]]> f7aca6d7f991226c0b52d7503a9dbb06 https://medicaldevicecourses.com/activity/p/13732/ Wed, 15 May 2019 17:07:43 -0400 I think Placebo-controlled trials is ethical and necessary because Using placebos in clinical research helps scientists more clearly understand whether a new medical treatment is safer and more effective than no treatment at all. This is not always easy because…   Read more»

]]> f076b06b5ca7cb57391ffb5ed6058722 https://medicaldevicecourses.com/activity/p/13725/ Wed, 15 May 2019 17:07:34 -0400 I think having a clinical background is very useful specially when you are dealing with the patient in clinical trials as a Bio-medical Engineer, I worked as a patient sitter in the hospital for 2 years and I also currently…   Read more»

]]> 9925e4f2a40dff1f48e76a4c26b28167 https://medicaldevicecourses.com/activity/p/13586/ Wed, 15 May 2019 17:06:17 -0400 One example of grand Strategy is Market growth. Market growth is a low-risk strategy compared to other, more encompassing, strategies. Instead of investing in research and development to create new product offerings, the market-growth strategy focuses on growing the market…   Read more»

]]> 3662fa7b8be82508f51029584e21995f https://medicaldevicecourses.com/activity/p/13579/ Wed, 15 May 2019 17:06:14 -0400 I think the best example for this is Coca-Cola, In the United States, the average person drinks one can of Soda a day, so a company like Coca-Cola, which has already acquired most of the people in the United States,…   Read more»

]]> 4cd678bd17762073ff61cea908c6af3e https://medicaldevicecourses.com/activity/p/13575/ Wed, 15 May 2019 17:06:12 -0400 Emotional Intelligence is something which is within us that helps us to sense how we feel and enables us to truly connect with others and form a bond. It gives us the ability to be present and listen to someone…   Read more»

]]> eb539dbea1b4c5096884bd3b3178b42a https://medicaldevicecourses.com/activity/p/13424/ Wed, 15 May 2019 17:04:46 -0400 The principal difference between public and privately held companies is that public companies have shares that can be publicly traded on a stock market. A privately held company might become a publicly held company by conducting an initial public offering,…   Read more»

]]> 866ddee848cca9d44cf4b1461aa64c36 https://medicaldevicecourses.com/activity/p/13419/ Wed, 15 May 2019 17:04:44 -0400 I did Research on Colgate Palmolive:- Net income and Diluted earnings per share in second quarter 2017 were $524 million.Gross profit margin was 60.1% in second quarter 2017. Operating profit decreased to $853 million in second quarter 2017 compared to…   Read more»

]]> 2eacfe71d519f700c5e01cce3365ede8 https://medicaldevicecourses.com/activity/p/13416/ Wed, 15 May 2019 17:04:42 -0400 I would prefer a S Corporation for my business S corporation has some appealing tax benefits and still provides business owners with the liability protection of a corporation. With an S corporation, income and losses are passed through to shareholders…   Read more»

]]> 9889701633982c0059e6282f16d2010a https://medicaldevicecourses.com/activity/p/13274/ Wed, 15 May 2019 17:03:30 -0400 I totally understand when people will complain about the quality, but hey I rather spend some money right now and higher some quality people instead I might have to lose my business. If I am running a business I would…   Read more»

]]> fba59010053a6440a961b9eb8dc5b909 https://medicaldevicecourses.com/activity/p/13273/ Wed, 15 May 2019 17:03:29 -0400 From a quality perspective, I will say that I have follow all the rules to make this product and I have all the documents in details from the start to end of the project with good GMPs. The quality person…   Read more»

]]> 29665a7e542389976f6788169dbaafe5 https://medicaldevicecourses.com/activity/p/13272/ Wed, 15 May 2019 17:03:28 -0400 I think the main issue is the ego the R&D department thinks they know every thing and what ever they do is 100% right, so in a situation when the quality people comes and tell them according to rules you…   Read more»

]]> 83719eeff8ad7bda9ed06c6645d01561 https://medicaldevicecourses.com/activity/p/13130/ Wed, 15 May 2019 17:02:11 -0400 Antimicrobial wound dressings is consider a combination product, it is mainly used to cover partial and full-thickness wounds the wounds and it also help to reduce the risk of infection. I think it will be consider as CDRH and it…   Read more»

]]> 8b66afba294726000c7df643ae7e1999 https://medicaldevicecourses.com/activity/p/13124/ Wed, 15 May 2019 17:02:08 -0400 For sure cigarettes kills people and based on FDA agenda they should regulates cigarettes but I guess they are not regulating normal cigarettes because it contain pure processed tobacco but it will be regulated by FDA in near future[1]. On…   Read more»

]]> bf4036510662fd9e389b4af0ee8a7547 https://medicaldevicecourses.com/activity/p/13120/ Wed, 15 May 2019 17:02:06 -0400 Antibiotic-releasing hip stem would be consider a combination device, it will follow in to CDRH based on the primary function of the device which is to replacing the bone. This device will be consider a class 3 because we will…   Read more»

]]> 79d10a79efe5bdc2448f64f5dea98139 https://medicaldevicecourses.com/activity/p/12974/ Wed, 15 May 2019 17:00:55 -0400 Personally I would do research in the industry, because it will help people right away. I think it is more appreciable and I can see it’s been used in the market and it’s really beneficial to people while I am…   Read more»

]]> 23f0e5d3aa022116773b7ed6c4760000 https://medicaldevicecourses.com/activity/p/12973/ Wed, 15 May 2019 17:00:54 -0400 At university professor more care about their research what I mean by that is they would like to perform studies on as much as different animals they can because they would perform some other studies on that for their research…   Read more»

]]> a3589371b1d566ae209591b9a2b14d50 https://medicaldevicecourses.com/activity/p/12971/ Wed, 15 May 2019 17:00:53 -0400 The first thing I want to point out is, I would never do such a study whee I know a lot of people and specially university because that relation of knowing people can definitely delay the our project purpose and…   Read more»

]]> 1fdaab716e0e0fb7ba489d504530f36f https://medicaldevicecourses.com/activity/p/12970/ Wed, 15 May 2019 17:00:52 -0400 To Study the Bio-compatibility of a brand new bio-material of which our device or product has been made, I will use ISO 10993-1 Test Matrix to determine what kind of test I should perform. And the decision of the test’s…   Read more»

]]> c8158158c7ee5f63a719b279eb3408c3 https://medicaldevicecourses.com/activity/p/12829/ Wed, 15 May 2019 16:59:29 -0400 Six Sigma is another management style, and study shows that firms who successfully implement this style is typically deliver better return on investment, return on sales, employment growth, stock growth and value growth. Pros: 1)Six Sigma strategy places a clear…   Read more»

]]> 3752937e6611f7d76f95dfbe9d0db627 https://medicaldevicecourses.com/activity/p/12825/ Wed, 15 May 2019 16:59:27 -0400 A bunch of related or non-related projects of an organization is known as Portfolio. It can consist of multiple programs or multiple projects without having a single program. A portfolio can have multiple non-similar projects without having a program, because…   Read more»

]]> 2bf4a26e5e630ae50c24ef5ae5088515 https://medicaldevicecourses.com/activity/p/12824/ Wed, 15 May 2019 16:59:26 -0400 I have never worked on a project where I have two project managers, but I am currently experiencing a similar situation where I have two managers in a lab and trust me it’s really helpful when you have two managers….   Read more»

]]> 8f6faf0fa148d63c5b4b3315774ed225 https://medicaldevicecourses.com/activity/p/12670/ Wed, 15 May 2019 16:58:04 -0400 I think it is a 70:30 is perfect, because Biomedical engineering is a very diverse field their is a so much course work that undergrad in BME is not good enough. As an undergrad I experienced orthopedic medical device Master…   Read more»

]]> d730f129dc8a7629dd0c3054f403457b https://medicaldevicecourses.com/activity/p/12668/ Wed, 15 May 2019 16:58:03 -0400 I totally agree with you Betty, I will tell the student the same thing to get more exposure to the industry environment and take masters courses which teaches about the how the things work in the Industry. Also try to…   Read more»

]]> bcf87a221fbfebfb91a326346032be35 https://medicaldevicecourses.com/activity/p/12666/ Wed, 15 May 2019 16:58:02 -0400 Based on my experience of working in both side of the field I will say they both have their pros and cons, it depend on the individuals what kind of career they want for them self. If I have to…   Read more»

]]> bd3a58ce199fe808fa9201c49f001e84 https://medicaldevicecourses.com/activity/p/5491/ Sun, 03 Dec 2017 23:45:32 -0500 I really like this course, it gives you good industrial insights on a structural manner. I think this course help me to Identify the suitable job profile, now I clearly know I am not a academia person and I am definitely going to the industry after I graduate. In my opinion this course teaches you how to apply the things you have learned in other…[Read more]

]]> 0 9b1f831358af98f39470c9d8e67cf104 https://medicaldevicecourses.com/activity/p/5447/ Sat, 02 Dec 2017 19:11:57 -0500 NDA is a contract, and contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state. Our firm practices patent law, which is federal, and so is interpreted uniformly throughout the United States. Another thing NDA gives you a limited level of…[Read more]

]]> 0 105d396b7a244d650071d86cb7f0b1c0 https://medicaldevicecourses.com/activity/p/5446/ Sat, 02 Dec 2017 18:55:35 -0500 I don’t think this is to restricted, it should be this way. I will say companies should not even pay $100 because even doctor is also is making enough money by doing the surgery and if the the doctors want best for their patient they have to use the best product out their in the market. My parents are nurses in India and I know a lot of doctors…[Read more]

]]> 0 4d33d9dbaead0130c4ef6f14bf75681b https://medicaldevicecourses.com/activity/p/5289/ Sat, 25 Nov 2017 22:10:59 -0500 I would like to work in Process-based organizational structures, because it is designed around the end-to-end flow of different processes, such as Research & Development, Customer Acquisition, and Order Fulfillment. Unlike a strictly functional structure, a process-based structure considers not only the activities employees perform, but also how…[Read more]

]]> 0 9e04a51b62d161ddbc818cc4e0551140 https://medicaldevicecourses.com/activity/p/5288/ Sat, 25 Nov 2017 21:50:18 -0500 In my opinion the best and most effective organizational structure is Circular Organizational structure the circular structure still relies on hierarchy, with higher-level employees occupying the inner rings of the circle and lower-level employees occupying the outer rings.What I mean by that is the leaders or executives in a circular organization…[Read more]

]]> 0 8ad6fc678566697ab1c92c378e4b7716 https://medicaldevicecourses.com/activity/p/5287/ Sat, 25 Nov 2017 21:28:56 -0500 I would say I want people in my team who have more knowledge in their department, because we are working on a project and we want what is best for the project. Sometimes working with people we have better relationship makes it harder because if they lack at some point it might hut out relationship but also it will affect the project, I will it…[Read more]

]]> 0 44cf67e90239d219a15684a7fe4d7e3c https://medicaldevicecourses.com/activity/p/5219/ Mon, 20 Nov 2017 03:16:25 -0500 ISO 31000:2009 provides principles and generic guidelines on risk management. ISO 31000:2009 can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services and assets. ISO 31000:2009 provides generic guidelines, it is not…[Read more]

]]> 0 b947def60f4339cca56bda53ee661fd8 https://medicaldevicecourses.com/activity/p/5218/ Mon, 20 Nov 2017 03:09:21 -0500 From low severity and for high severity of risk:-
1) Accept The Risk:- This is a good strategy to use for very small risks – risks that won’t have much of an impact on your project if they happen and could be easily dealt with if or when they arise. It could take a lot of time to put together an alternative risk management strategy or take act…[Read more]

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