https://medicaldevicecourses.com/members/nsam9295/activity/ Activity feed for nsam9295. Sat, 16 May 2026 08:00:10 -0400 https://buddypress.org/?v= en-US 30 hourly 2 55a76cdd09f3bdce2bdd267930185626 https://medicaldevicecourses.com/activity/p/19242/ Mon, 09 Dec 2019 04:42:57 -0500 It may seem restricted, however, I would like to offer a different perspective towards these restrictions. Let’s say there are two companies who are fighting for one physician to consult with. Company A is a gigantic firm with a lot…   Read more»

]]> 985c5ea42440b6b8be9d423ddd332c87 https://medicaldevicecourses.com/activity/p/19241/ Mon, 09 Dec 2019 04:34:08 -0500 Like all legal documentation that binds you to a legal contract. It is extremely important for you to read through the whole documentation and you 100 percent agree and understand all there is written in the agreement. And if it…   Read more»

]]> 2bbcc8bdd6de152fd703b16db760c9fd https://medicaldevicecourses.com/activity/p/19240/ Mon, 09 Dec 2019 04:27:46 -0500 Both verbal and written consent or agreement has legal standing. However, verbal consenting requires a lot more effort to record and preserve. A written agreement both parties sings the original documents and both keep the documentation. Whereas verbal agreement can…   Read more»

]]> afd77063dff6b1db050ba07a98af124e https://medicaldevicecourses.com/activity/p/19180/ Mon, 25 Nov 2019 03:54:09 -0500 I believe I would have the skill set to excel in both roles however I think I will enjoy it more if I work as upper management. And since there are numerous studies where if you do what you like…   Read more»

]]> de55d63b2125d540adef02706e1b284b https://medicaldevicecourses.com/activity/p/19177/ Mon, 25 Nov 2019 03:15:35 -0500 There is no perfect organization type which will be the gold standard. In addition, there is a lot of factors that can affect efficiency as well. Therefore it is important you discuss the method that has previously worked before to…   Read more»

]]> 5f42e9b3379e6139992f7842ca9f9981 https://medicaldevicecourses.com/activity/p/19175/ Mon, 25 Nov 2019 02:54:42 -0500 It is important to first have a great project leader with lots of experience with managing people. I strongly believe that one of the main jobs of the project leader is to manage team members and also play a support…   Read more»

]]> a2b31f6e5f2532fef8f3a8b00d090c22 https://medicaldevicecourses.com/activity/p/19122/ Mon, 18 Nov 2019 04:57:23 -0500 Like in the lecture the risk management process should be designed in a way where it starts at the very beginning of the project to the end of when the product’s life ends. Especially for medical products. PMS I think…   Read more»

]]> c8191541eca85b56c8189507223b3ac7 https://medicaldevicecourses.com/activity/p/19121/ Mon, 18 Nov 2019 04:50:46 -0500 I am currently working in a university setting rather than an industry setting. Therefore, we will have a different approach however the main fundamental idea is the same. For lab settings, we do a more concentrated dive in literature and…   Read more»

]]> 276f5ae7ebe873243ddd017e1db06a9f https://medicaldevicecourses.com/activity/p/19120/ Mon, 18 Nov 2019 04:40:04 -0500 I believe it is important to have each department send a representative to the meeting. That way when brainstorming and finding risk it will be a lot more efficient and effective.  That way the project manager is able to have…   Read more»

]]> b6752531226aab32b42f56b6e3b1c589 https://medicaldevicecourses.com/activity/p/19060/ Mon, 11 Nov 2019 03:51:54 -0500 I would like to point out a crucial point. The manufacturing process or the design transfer success rate will depend on how well the outsourcing manufacturing factory understands the steps before the design transfer phase. In other words, no matter…   Read more»

]]> 293ed5b8c680bb1d74c08e3dc48467e7 https://medicaldevicecourses.com/activity/p/19058/ Mon, 11 Nov 2019 03:43:56 -0500 Since a lot of ppl touched on the FDA portion of the question, I will try to help you understand the other portion of your question. In theory, there are unlimited ways to test if the product is safe by…   Read more»

]]> ac9942d537358eec5417ca2d12466493 https://medicaldevicecourses.com/activity/p/19057/ Mon, 11 Nov 2019 03:34:51 -0500 Well, the possibilities are endless. Even with a well thought out design control documents, there are possibilities of things going wrong due to us being human beings and not able to predict all the possible outcomes. The only job of…   Read more»

]]> 6ef4da9b4ed99949d78666aa10e1f459 https://medicaldevicecourses.com/activity/p/19001/ Mon, 04 Nov 2019 04:17:13 -0500 I believe design control should be implemented in every step of the process from start to end of the product’s life. It is important to numerically or for some cases observationally be able to determine how well you are doing…   Read more»

]]> 5bd807f5ea2600b88f2ed0f8e246d3fc https://medicaldevicecourses.com/activity/p/18998/ Mon, 04 Nov 2019 04:03:16 -0500 I believe some way to record what has been discussed in meetings are extremely important in terms of team success and organizations. It does not necessarily have to be in minutes. However, it is one method where one can read…   Read more»

]]> b4482fe965b2cdf0e662bd1a26c90b98 https://medicaldevicecourses.com/activity/p/18997/ Mon, 04 Nov 2019 03:56:31 -0500 For any new device, it should be good practice to always have a way to test and minimize errors or risks before the product is sold to customers. It is extremely important to do this before and well. Since once…   Read more»

]]> 4e825280b9b9501219165ccac66aae30 https://medicaldevicecourses.com/activity/p/18943/ Mon, 28 Oct 2019 03:28:26 -0400 Any job in the world does not require previous experience to be good at. The main advantage for people who are hiring is that if someone has previous experience the time required for them to train them decreases significantly. Also,…   Read more»

]]> c896abc9cd303ffe40c2b3630126805b https://medicaldevicecourses.com/activity/p/18940/ Mon, 28 Oct 2019 02:23:38 -0400 Placebo is being used extensively in the field of pharmaceutical clinical trials. It is important to acknowledge that the extent of how the human mind places a role in affecting the human body both positively and negatively. And the only…   Read more»

]]> ad3dc07a02c8112e58a5c9fc82a80f68 https://medicaldevicecourses.com/activity/p/18939/ Mon, 28 Oct 2019 02:09:59 -0400 I would like to be a Research Assistant. This is more for Ph.D. students in a lab setting. Where the PI(Principal Investigator). Since I believe it is a high return for low risk. Depending on your P.I. you are able…   Read more»

]]> eb23d6577abecd32cf36192588bb0dfe https://medicaldevicecourses.com/activity/p/18883/ Mon, 21 Oct 2019 03:42:37 -0400 This all depends on the person and what they like. Due to the development of social media and the internet. Advertisements have changed and it has such a diverse form as well. I am not a big fan of advertisements…   Read more»

]]> 504af477fc9c41cf3cba8eb0c52d2dfc https://medicaldevicecourses.com/activity/p/18881/ Mon, 21 Oct 2019 03:36:27 -0400 A lot of marketing espcially these days applys a lot of what is being researched in the psychological field. These days a lot of advertisements are made with a psychological research background. Human brains are complex especially the unconsciousness of…   Read more»

]]> 29487e03b7bb8443d1116700352339a7 https://medicaldevicecourses.com/activity/p/18878/ Mon, 21 Oct 2019 03:28:55 -0400 It happens all the time. Large companies will use any tricks up there sleeves to make a person by a product. I would say that these days its almost true that you do not really need an outstanding product to…   Read more»

]]> 304f3221d8284134b76cbb1371486908 https://medicaldevicecourses.com/activity/p/18792/ Sat, 12 Oct 2019 18:49:06 -0400 Depending on the company’s objectives, size, the field of engagement, I believe the measure of success should be altered. For small companies, one mistake could mean the end of the company’s life or it will take them a lot longer…   Read more»

]]> 9d3f7f223890e1edcb87dcf68a448135 https://medicaldevicecourses.com/activity/p/18791/ Sat, 12 Oct 2019 18:13:16 -0400 I am currently, in a partnership with one of my close friends back home. We both share the same passion and also are very interested in building our own establishment one day. He is in charge of the management and…   Read more»

]]> 747b6b700c33e003e17dfc61bbad1818 https://medicaldevicecourses.com/activity/p/18790/ Sat, 12 Oct 2019 17:36:42 -0400 I would like to add more to what @mmejia said. LLP and LLC are the most common and most used types of entities used for small start-up companies. LLC is more chosen by small businesses that do not focus on…   Read more»

]]> 609f77d69238cc27305b4556555bba95 https://medicaldevicecourses.com/activity/p/18747/ Mon, 07 Oct 2019 02:45:41 -0400 It is important for both parties to keep in constant conversations. When a company finds a problem with a certain regulation they should try the best to report it to the FDA or ISO and to see if they can…   Read more»

]]> 23a04d3bb1b6e0a253ad967f118605ed https://medicaldevicecourses.com/activity/p/18745/ Mon, 07 Oct 2019 02:37:16 -0400 With any conflicts within groups, the key thing is communication. To explain in detail, both parties should at the beginning of the conversation make sure they understand each other’s party and that both departments exist for a valid reason. And…   Read more»

]]> 7cf1e090cd21d91b83409acc05cb8ba4 https://medicaldevicecourses.com/activity/p/18744/ Mon, 07 Oct 2019 02:31:18 -0400 There are many companies that have already implemented AI in quality management and also product development as well. For example, there is a french company called Pharnext who has recently been able to develop a drug for CMT1a using AI…   Read more»

]]> 48b71693785eedc10991db6cfd16f182 https://medicaldevicecourses.com/activity/p/18685/ Mon, 30 Sep 2019 03:13:12 -0400 There can be lots of problem with this which can be hard to fix when you are trying to develop a medication by oneself. One is that gigantic pharmaceutical companies have big labs and big research team to test and…   Read more»

]]> 5943bd33d2d456c17aea52654b957a9e https://medicaldevicecourses.com/activity/p/18684/ Mon, 30 Sep 2019 03:07:02 -0400 This response is somewhat related to the question above but to change perspectives a little bit. Why do you think in the majority of countries drugs that are meant for ADHD are banned(Korea and Japan to name a few). To…   Read more»

]]> 9e08cf9fde77a8db4fb38e08d1cec172 https://medicaldevicecourses.com/activity/p/18681/ Mon, 30 Sep 2019 02:56:24 -0400 Recall can be delayed for a variety of reasons. One of the biggest reason, in my opinion, is that majority of the recalls of the medical devices are “In most cases, a company (manufacturer, distributor, or other responsible party) recalls…   Read more»

]]> d3a4af0d5c8e87319d55b5785e68903d https://medicaldevicecourses.com/activity/p/18621/ Mon, 23 Sep 2019 02:06:51 -0400 I believe it is important to not just distinguish the two worlds separately however incorporate the two worlds together. Both fields have the pros and cons and I believe that it is not correct to choose between the two different…   Read more»

]]> 13791510740e88e608268c7456d2551f https://medicaldevicecourses.com/activity/p/18620/ Mon, 23 Sep 2019 01:55:57 -0400 When you outsource the experiements there are lots of things that could go wrong. Therefore, you have to take multiple steps and make protocols for problems you see happening. The more specific and well thought out your protocol are you…   Read more»

]]> 80847aff15b19f43dde65d1be87f2c6f https://medicaldevicecourses.com/activity/p/18619/ Mon, 23 Sep 2019 01:46:28 -0400 I am currently starting to do clinical trials and I have been doing a pre-clinical trial for my project. Anything you could think about can be a reason for this step to fail or prolong the process. For example, it…   Read more»

]]> ff6815f9657ed0c16ddd2ffbfc50dbe6 https://medicaldevicecourses.com/activity/p/18567/ Mon, 16 Sep 2019 03:29:59 -0400 @tulikadaspI would like to add to your comment. I think it is always important for a beginner to start by researching and using processes that are outlined by other professionals in the industry. However, it is very important that you…   Read more»

]]> 61029e0b45f7c4d2c0c28b5ee3737c0a https://medicaldevicecourses.com/activity/p/18565/ Mon, 16 Sep 2019 03:05:29 -0400 I am currently managing a group of students back home and working on a project to create medical devices to help people with CMT to exercise. It is currently at an early stage. I have a non-engineering partner who has…   Read more»

]]> 21f72aef395282e676b8f13b551be234 https://medicaldevicecourses.com/activity/p/18562/ Mon, 16 Sep 2019 02:45:32 -0400 I would like to suggests that one more group of people should be invited/added to the kick-off meetings: the end-users or patients. Ultimately the end-users are the individuals who are going to use the medical products developed, therefore, they should…   Read more»

]]> ef321f7b2461c70e9cd65c8225df617c https://medicaldevicecourses.com/activity/p/18559/ Mon, 16 Sep 2019 02:23:03 -0400 I would like to suggests that one more group of people should be invited/added to the kick-off meetings: the end-users or patients. Ultimately the end-users are the individuals who are going to use the medical products developed, therefore, they should…   Read more»

]]> 4632e4ebd76cefc08e16d07ad8ccdc3d https://medicaldevicecourses.com/activity/p/18440/ Sat, 07 Sep 2019 02:31:54 -0400 @puneetQuick question for you and for other students who are working and pursuing their master’s degree. For people in the industry was it not hard to juggle work, school, personal life. Since we are all human beings and dont have…   Read more»

]]> 94466254e2aae244e8f40a2be0e1703d https://medicaldevicecourses.com/activity/p/18439/ Sat, 07 Sep 2019 01:14:25 -0400 Quick question for people who have gotten there Ph.D. and went into industry. I heard a rumor that once you get your Ph.D. since your thesis is on a very specific topic it actually limits your opportunity when it comes…   Read more»

]]> 26a5294a790f44cee7886fe0ebfaabe0 https://medicaldevicecourses.com/activity/p/18438/ Sat, 07 Sep 2019 01:01:18 -0400 I do not like the idea that the school decides the ratio. Especially, once you are done with undergraduate studies you are more aware of what you would like to do with your degree. Therefore, if one desires more practical…   Read more»

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