https://medicaldevicecourses.com/members/gh56/activity/ Activity feed for gh56. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 803a7b7d32d59f9c9575a36f4409d1b1 https://medicaldevicecourses.com/activity/p/12575/ Wed, 15 May 2019 16:57:16 -0400 since already many have talk about some of the examples, there are some benefits of ECO. following good ECO practices it will make thing easier when documenting a full history of what change have been made to a product and…   Read more»

]]> c2d24622632f51376e7ba2115ba4f63a https://medicaldevicecourses.com/activity/p/12570/ Wed, 15 May 2019 16:57:13 -0400 since everyone have mention about why SOP should be required during research phase, i want to add some information about SOP. SOPs should be reviewed by appropriate individuals. Reviewers could include colleagues who will be using the SOP, Quality Assurance…   Read more»

]]> 0d2965c45ebbe333b9370c943ea3ddc6 https://medicaldevicecourses.com/activity/p/12569/ Wed, 15 May 2019 16:57:13 -0400 yes i do believe that Guidance documents are very important because this documents are prepared for FDA staff, regulated industry, and the public that describe the agency’s interpretation of or policy on a regulatory issue. Guidance documents include, but are…   Read more»

]]> 408aa13a5941dc26bf177ddeb6344ac0 https://medicaldevicecourses.com/activity/p/12568/ Wed, 15 May 2019 16:57:12 -0400 i dont have experience with this, and since a lot of student have answer i want to add some information about the Authorisation procedure. it said that the Full copies of the marketing authorisation application file are sent to a…   Read more»

]]> 05cc0654674b93f71f17c761d30020a0 https://medicaldevicecourses.com/activity/p/12567/ Wed, 15 May 2019 16:57:12 -0400 The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of these regulatory challenges by the Food and Drug Administration. According to a survey funded by the Institute for…   Read more»

]]> 16c48e3f1b64a210fe8665906ea899c5 https://medicaldevicecourses.com/activity/p/12566/ Wed, 15 May 2019 16:57:11 -0400 It seem that a lot of people here had agree with me that Clinical research wouldn’t take this career path, one thing that I do like was that CRA can travel for free and work for home that’s one of…   Read more»

]]> d4440e8c3e049ffa396aaed59a62f8e8 https://medicaldevicecourses.com/activity/p/12557/ Wed, 15 May 2019 16:57:07 -0400 Very good question, this simulation have help me understand how actually, some of the stuff I would be dealing in the industry and how I have be knowledge about many factors. All the simulation were very interesting, each dealing differently…   Read more»

]]> 722a8d48d01723f35b5f9d24ef9b19ef https://medicaldevicecourses.com/activity/p/12486/ Wed, 15 May 2019 16:56:27 -0400 Yes, I do have to agree with Fady Khalla post, it can varies depending on the application that this device is going to be used. As fady khalla mention, depending of the used of the device the risk could change….   Read more»

]]> cb5156bed31f2b7a3a40d02b029159d1 https://medicaldevicecourses.com/activity/p/12474/ Wed, 15 May 2019 16:56:22 -0400 Hi neb2 from the research i did from this week lecture i found few examples that might help you, there is a lot of them but im just going to provide some of them. for NSR; -Digital Mammography [Note: an…   Read more»

]]> 48a282f1c34fbb470c95fccfa515ebd4 https://medicaldevicecourses.com/activity/p/12362/ Wed, 15 May 2019 16:55:18 -0400 Pros to internal audits When an internal audit is performed you can be sure that a proper accounting system is going to be introduced into your company. If you have never worked in an accounting office or seen what goes…   Read more»

]]> 4dca48d88ec6c36663f76e829d8a8975 https://medicaldevicecourses.com/activity/p/12332/ Wed, 15 May 2019 16:55:02 -0400 It is true that for startup companies not having preexisting GMP as a foundation it will cause a lot of problem, like everyone has mention in this post. What we need to look at here is that even though it…   Read more»

]]> 23315774365e1819962481c6941bafae https://medicaldevicecourses.com/activity/p/12331/ Wed, 15 May 2019 16:54:56 -0400 hi neb2 very good question i was thinking about this when i was looking at Dr. Simon lecture, what i believe is that a process approach is a management strategy, where a managers is able to control and manage the…   Read more»

]]> 98f81c82301277349dd4258d32d2b2e6 https://medicaldevicecourses.com/activity/p/12324/ Wed, 15 May 2019 16:54:53 -0400 GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must…   Read more»

]]> 6e13558ec447bcba645b4f8e5c238266 https://medicaldevicecourses.com/activity/p/12259/ Wed, 15 May 2019 16:54:16 -0400 Hi luisa thank you so much for your input yes it seem like it wasnt the same but now i can do see the difference, because what i was thinking i guess it was different thank you for the clarification….   Read more»

]]> dfd5ab7ee4bd6eb50d6b9c4bfbe9d05f https://medicaldevicecourses.com/activity/p/12258/ Wed, 15 May 2019 16:54:15 -0400 Hi jnm22 thats very interesting anf very scary, because it could affect many of their customers and maybethe company might get sue to some tragic, so do you know how they were able to fix or how they found out…   Read more»

]]> f4fddf70029141122480961e79d2b9ef https://medicaldevicecourses.com/activity/p/12257/ Wed, 15 May 2019 16:54:15 -0400 I agree with both interpersonal skills and business skills because this will help to either fix or make a good deal with someone you are dealing. So yes you kind need both of this skills at the same level, they…   Read more»

]]> d9f20903baea8c80284c35f2d705ab07 https://medicaldevicecourses.com/activity/p/12189/ Wed, 15 May 2019 16:53:37 -0400 I believe that the most expensive is Introduction Stage, because the company is launching a new product. Further, the size of market for the product is initially low and thus sales are low. Costs of research and development, testing, and…   Read more»

]]> f09afeb94f64d07f25eabdbcb4bc6b90 https://medicaldevicecourses.com/activity/p/12188/ Wed, 15 May 2019 16:53:37 -0400 I haven’t had no experience in product failures but I can figure out ideas that how a product can fail. I believe that having a poor budgeting could make a product fail, sometime teams look at different ideas, or plan…   Read more»

]]> d5414f1321b7a486e768ea1b4043c916 https://medicaldevicecourses.com/activity/p/12074/ Wed, 15 May 2019 16:52:34 -0400 Hi everyone, When i graduate from my undergrad i was really lost on what career path i wanted to follow so i decided to do my master and maybe try to learn more and maybe figure out by than which…   Read more»

]]> 9111972986b668650cea222b0bb4bbe8 https://medicaldevicecourses.com/activity/p/12072/ Wed, 15 May 2019 16:52:33 -0400 Unfortunately I haven’t experience with this type of documentation in the industry since i do not work yet for a medical device company that would allow me to see or do this type of documentation, so the only experience I…   Read more»

]]> eefc0bb12f35297e2a10d0e7888758fe https://medicaldevicecourses.com/activity/p/12066/ Wed, 15 May 2019 16:52:30 -0400 Hi Fady, I have to agree with chris vasquez, there is no need to revalidating something that is not being move. what is important here is understand what went wrong with me machine it seem that some components of the…   Read more»

]]> 92fd417e9998ce707b3dda13fe547b3e https://medicaldevicecourses.com/activity/p/11988/ Wed, 15 May 2019 16:51:43 -0400 I haven’t had no experience in this aspect but I did some research on different type of validation and I found that, self-documenting verification method is the traceability matrix. This method is particularly useful when the design input and output…   Read more»

]]> 8bee2df8de8c1486b6421d9fda7dbad0 https://medicaldevicecourses.com/activity/p/11987/ Wed, 15 May 2019 16:51:43 -0400 Hey guys we have talk about IQ, OP and PQ about Syringe Filling Process – filling syringes with an injectable bone void filler and Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft….   Read more»

]]> e9da5b8c9888375e450b3316c986be35 https://medicaldevicecourses.com/activity/p/11985/ Wed, 15 May 2019 16:51:42 -0400 Hi Andrew, I have to agree with Fady Khalla on your IQ but never the less I think most of people have gave a lot of input on the syringe filling process for IQ, OQ, and PQ. so im just…   Read more»

]]> 1918d3f0b3b64bddfa41829be2a4728c https://medicaldevicecourses.com/activity/p/11870/ Wed, 15 May 2019 16:50:32 -0400 I wish i had experience on QMS for me it seems very important since quality management system can be defined as the implementation of dedicated activities in a project to obtain continuous improvement, and enhance the organization efficiency. The foremost…   Read more»

]]> 868c4a7b1701f6035092c2ae07ddcfd7 https://medicaldevicecourses.com/activity/p/11828/ Wed, 15 May 2019 16:50:09 -0400 I have to agree with Jnm22 and mj34 but I want to add a little more about this that I think is important. We first need to understand that post-market-surveillance is to pretty much monitoring a device after is out…   Read more»

]]> 6a5e4866a2c6e735ce9879e5c8b3bf8d https://medicaldevicecourses.com/activity/p/11826/ Wed, 15 May 2019 16:50:07 -0400 A written method of controlling a practice in accordance with predetermined specifications to obtain a desired outcome. SOPs are written steps to explain good manufacturing practices (GMP), plant safety routines, financial controls to secure assets, or IT security measures that…   Read more»

]]> fdbeca130800c85ebdd9d9bdb6b93037 https://medicaldevicecourses.com/activity/p/11766/ Wed, 15 May 2019 16:49:33 -0400 nice information you have found neb2 i have post two more that i think it crucial to know all the surveillance strategies. 4. Postmarket Surveillance Studies — The FDA may order a manufacturer of certain Class II or Class III…   Read more»

]]> 1bc651255b2947b6c1f486283f9bc7d9 https://medicaldevicecourses.com/activity/p/11723/ Wed, 15 May 2019 16:49:03 -0400 i see a lot of you have gave their opinion on the matter of how to trying to get the best strategy to take when the validation and verification had fail. Now we know is really bad when this two…   Read more»

]]> 0f13d07d99b7f94d0b1909c2ed58ed4f https://medicaldevicecourses.com/activity/p/11717/ Wed, 15 May 2019 16:48:59 -0400 I have to defiantly agree with neb2, the DHF is a lot more useful than the design dossier since this file have detailed information bout the design, function, composition, use, claims and clinical evaluation of the medical device and it…   Read more»

]]> 450d7c7290519b56435e1e4da46744ac https://medicaldevicecourses.com/activity/p/11716/ Wed, 15 May 2019 16:48:59 -0400 When talking about verification is like asking our self are we building the system right? We always have to consider this question when we are talking bout verification. It is important that the process of the evaluating products of a…   Read more»

]]> c5b4816163e5bb9fe0a80951833363b3 https://medicaldevicecourses.com/activity/p/11542/ Wed, 15 May 2019 16:47:29 -0400 Hi Jnm22, Thank you for providing this information, it was interesting in actually looking up the wake forest I did not know nothing about it. It was interesting in reading it about it. Yes I do I agree on this…   Read more»

]]> d8cd7481ee399f658ed0c36379567d99 https://medicaldevicecourses.com/activity/p/11470/ Wed, 15 May 2019 16:45:14 -0400 I have to 100% agree with you I love your post, we have seen what 3D printing can do and how it can advance the technology in the medical field which allow us to help more patients health, which this…   Read more»

]]> 4cd4fd82dccc3e1bceee5e54d5a31a4b https://medicaldevicecourses.com/activity/p/11469/ Wed, 15 May 2019 16:45:13 -0400 I want to talk a little more about the 3-D printing , we have learn that 3D printing is becoming more popular now days, the cost of getting one is really cheap, and many people can just go and purchase…   Read more»

]]> c0dc729eb41b7b46bd3f98fbca3650b6 https://medicaldevicecourses.com/activity/p/11416/ Wed, 15 May 2019 16:44:47 -0400 I have too semi agree with you, yes the written agreement is important to be able to have strong argument in the court this will allow you to have a better chance to be able to win if something went…   Read more»

]]> 1639e29b9afb945e514a90de7e8a6355 https://medicaldevicecourses.com/activity/p/11382/ Wed, 15 May 2019 16:44:26 -0400 I do not have experience with this matter since I haven’t been able to work in a company where I have to deal with this matter but I do have to agree with Zmh4 on his point of view, it…   Read more»

]]> 701fa6b79b65faf94df99ba9ae0163e6 https://medicaldevicecourses.com/activity/p/11381/ Wed, 15 May 2019 16:44:26 -0400 When I sign for this class I wasn’t sure what was about, but I am happy I took it because it allows me to learn different type of work you can do in the medical device industry. With the knowledge…   Read more»

]]> 64f9b6ded088d1432993ffe72149ae3e https://medicaldevicecourses.com/activity/p/11261/ Wed, 15 May 2019 16:43:25 -0400 I haven’t had the opportunity to be part of this kind of organization, but neither the less, both organization have their advantages and disadvantages as how Dr. Simon mention in the lecture. Both organization seem pretty cool to be part…   Read more»

]]> 33ce5f6a69daad3fc61048946f5e9b39 https://medicaldevicecourses.com/activity/p/11260/ Wed, 15 May 2019 16:43:25 -0400 You have raise an actually good question, if you don’t have a choice to pick your team and is already selected for you yeah that would be a different problem. I believe your list accurate and it make sense, but…   Read more»

]]> acf27947d2c21a26f99dc0fc5d045ea0 https://medicaldevicecourses.com/activity/p/11259/ Wed, 15 May 2019 16:43:24 -0400 This is a little difficult question to answer, ideally you should pick the best at the department roles that way everyone knows their role and try to focus on the goal project, but I think that would be only in…   Read more»

]]> f01f8b1c749aace05f34adbc6fe94ee6 https://medicaldevicecourses.com/activity/p/10966/ Wed, 15 May 2019 16:38:23 -0400 I have to disagree with you little bit, yes the communication management plan is important but I believe that every part of the design development is necessary. So I believe each have their own importance in the document and it…   Read more»

]]> ccc3e279656d50df66a0480e95adc3ba https://medicaldevicecourses.com/activity/p/10965/ Wed, 15 May 2019 16:38:22 -0400 I have to agree with you on this part a lot of smaller companies do hire separate companies to be able to manufacture their device since for them it cost efficient, if they try to do it for themselves that…   Read more»

]]> 4e39fa56c654571aa7d6800c5736ffd0 https://medicaldevicecourses.com/activity/p/10962/ Wed, 15 May 2019 16:38:21 -0400 I haven’t had the change to have a design review meeting in an industry but I have done it when I was doing my Capstone project, we used to have a lot of meeting because we used to keep changing…   Read more»

]]> b2a1141e536d7f4f57127ab995b54a26 https://medicaldevicecourses.com/activity/p/10960/ Wed, 15 May 2019 16:38:20 -0400 I do have to agree with most of what you have said about design verification, we all know that design verification is pretty much to whatever it was written in the DID document it must be verified to make sure…   Read more»

]]> a368c5ea882d0c59f47999d3dc987cd4 https://medicaldevicecourses.com/activity/p/10959/ Wed, 15 May 2019 16:38:19 -0400 I want to tell you that i believe that meeting minutes is extremely important specially when people have so much work and they might forget something this will allow to go back and figure out what was said. For me…   Read more»

]]> 2539f10e4161770275d2f8194079cf08 https://medicaldevicecourses.com/activity/p/10532/ Wed, 15 May 2019 16:34:21 -0400 Hello everyone, As we come to a close to finish AMDD we have learn a lot of new material that we can apply to our careers. I know some of the people here have jobs and had seem some of…   Read more»

]]> 434190e2e16765b554e78ae486b350e6 https://medicaldevicecourses.com/activity/p/10522/ Wed, 15 May 2019 16:34:13 -0400 Hello everyone, so this week lecture is about Clinical Research and we learn a lot about it, i personally do not see myself working on this the reason is because it doesn’t seem fun or i don’t think i will…   Read more»

]]> ef1578e0ade345cfb23ec4256f25e13f https://medicaldevicecourses.com/activity/p/10508/ Wed, 15 May 2019 16:34:06 -0400 In Dr Simon, he talk briefly about correction vs corrective action. What I understood from the lecture Is that correction is any action that is taken to eliminate a non-conformity, and corrective action are steps that are taken to remove…   Read more»

]]> ef89463367744e7fec6783f2fc87a6fa https://medicaldevicecourses.com/activity/p/10507/ Wed, 15 May 2019 16:34:05 -0400 In Dr Simon he talk about Corrective and preventative actions (CAPA) and this topic is important to know and we know that CAPA system aims to identify, eradicate, and reduce the chance of adverse events recurring and that is why…   Read more»

]]> 53acd82221bab18ee88581b3d0f2d1d9 https://medicaldevicecourses.com/activity/p/10491/ Wed, 15 May 2019 16:33:58 -0400 In Dr. Simon Lecture we learn 4 things that a product manager need to have which are: -Understand factors that affect the product sales -Compare competitive products and services -Stay informed about industry and market data -Create a story behind…   Read more»

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