https://medicaldevicecourses.com/members/shavondraleak/activity/ Activity feed for shavondraleak. Fri, 24 Apr 2026 23:19:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 51175b634911f89d76306b436cd97950 https://medicaldevicecourses.com/activity/p/25727/ Tue, 19 Apr 2022 04:14:08 -0400 So I remember my interview for a company I worked for previously hired me as a result of my stance on confidentiality and being able to hold trade secrets. The interview was very laid back but with about five managers…   Read more»

]]> e1dd20a699b8aa212e05fc12160cd68c https://medicaldevicecourses.com/activity/p/25726/ Tue, 19 Apr 2022 04:00:43 -0400 DuPont Tate & Lyle LLC is a joint venture company.  Tate & Lyle is a world-leading renewable food and industrial ingredients company and Dupont is a global science innovator. Individually I believe that both have a functional organizational framework. However,…   Read more»

]]> f7c848be75516917dd07cfd5bb6b5723 https://medicaldevicecourses.com/activity/p/25725/ Tue, 19 Apr 2022 03:56:27 -0400 As we have become a global society and business is no longer local but international with the touch of a button transactions can take place the matrix-based organization seems to be the best fit model. With the pandemic exposing and…   Read more»

]]> ed7697bfa2014b32f188e403c56f91db https://medicaldevicecourses.com/activity/p/25600/ Fri, 15 Apr 2022 05:11:19 -0400 What are some benefits of implementing a risk management assessment for a device? Give the pros and what can be seen as potential cons if there are any? A risk assessment is a process to identify potential hazards and analyze what…   Read more»

]]> 7d1a3c7d66edce2a131678457d83fa0e https://medicaldevicecourses.com/activity/p/25599/ Fri, 15 Apr 2022 04:52:18 -0400 If you fail to plan then your plans will fail. Planning is the greatest investment of time, talent, and thought.  I believe Risk Management is a vital part of the planning phase in any product design or development, especially in…   Read more»

]]> 91a63ae5dbd0c584180f4ba414ab2d89 https://medicaldevicecourses.com/activity/p/25598/ Fri, 15 Apr 2022 04:36:06 -0400 The major ISO regulation governing Risk Management is the ISO 14971 adopted in 2007. Risk management is a design input and is a part of the product design lifecycle. Evaluation of risk for a medical device includes apparent risks and…   Read more»

]]> 00266f31fa16451dca5c10493beda894 https://medicaldevicecourses.com/activity/p/25426/ Tue, 05 Apr 2022 10:13:31 -0400 As I  am going through this course and gaining more knowledge on medical devices and the process which it takes for them to reach the market I realize it goes back to the basics. As a scientist, the scientific method…   Read more»

]]> 8a7f194889b571fb1f2d54e377bb4e89 https://medicaldevicecourses.com/activity/p/25425/ Tue, 05 Apr 2022 09:49:43 -0400 There are nine components that make up design controls that build from one to the other. Knowing the goal of medical device development and meeting that goal is the outcome of the design controls. I believe the planning aspect is…   Read more»

]]> d242da840af92eb700ba3707993393df https://medicaldevicecourses.com/activity/p/25424/ Tue, 05 Apr 2022 09:11:07 -0400 According to the lecture, there is a difference between verification and validation in most cases. However, sometimes the verification is interchangeable with validation. If the product that you are producing is verified and the input equals the output all specs…   Read more»

]]> f25dbb844127f3ab1b3455c6e8b03819 https://medicaldevicecourses.com/activity/p/25391/ Sun, 03 Apr 2022 03:13:09 -0400 98b137dee6898cbe2b3531a6df7a3697 https://medicaldevicecourses.com/activity/p/25390/ Sun, 03 Apr 2022 03:12:35 -0400 As a lab technician, it is one of those on-the-job training sessions you must put into practice daily. Good clinical practices (GCP) are the guidelines that are in place to ensure safety. The FDA sets the guidelines for any industry…   Read more»

]]> 000416195f07ec15b177cc4d0908e731 https://medicaldevicecourses.com/activity/p/25389/ Sun, 03 Apr 2022 03:02:08 -0400 Big Pharma has established its position and those names and reputations stand highly recognized. However, the CRO is a contract research organization that is a life sciences company that provides support to the pharmaceutical, biotechnology, and medical device industries in…   Read more»

]]> 2cd30c5c4a238493e8afdd1f7ab00551 https://medicaldevicecourses.com/activity/p/25387/ Sun, 03 Apr 2022 02:43:02 -0400 FDA regulations require a clinical trial before a product is set to market. Clinical Trials are very essential both on medical devices and on drugs. After pre-clinical data is approved it is imperative that it be tested in a controlled…   Read more»

]]> a02d2609298b626adb016e745ae6dd19 https://medicaldevicecourses.com/activity/p/25165/ Fri, 25 Mar 2022 20:39:10 -0400 A key to success is the ability to manage yourself well. Personal management is perhaps one of the most underdeveloped tools of an individual yet highly sought after professionally and publicly. Yesterday I saw some clips of Ketanji Brown Jackson’s…   Read more»

]]> 20d28c813d994e7c57ba6934e385f7bc https://medicaldevicecourses.com/activity/p/25163/ Fri, 25 Mar 2022 19:41:36 -0400 According to Merriam Webster, a mission statement states the purpose or goal of a business or organization. The company’s mission statement emphasizes its ongoing commitment to meeting the needs of the community. The purpose of the mission statement is to tell…   Read more»

]]> c4cfadd64c30ad91a7437bd9a941b22b https://medicaldevicecourses.com/activity/p/25152/ Thu, 24 Mar 2022 16:30:19 -0400 The 5P’s of marketing with the fifth P being participation/people are changing the way marketing is presented on digital platforms. Engaging patients, consumers, participants in a non-face-to-face sale involves ingenuity and being able to be personable and convey your message…   Read more»

]]> 4ad12b041ed551e20c69a8f89e6c6e3e https://medicaldevicecourses.com/activity/p/25077/ Sat, 19 Mar 2022 03:05:09 -0400 The streamlining of processes is cost-effective in most cases as far as consistency and conformity across the board.  “On October 5, 2021, FDA issued a final rule on the De Novo Classification Process.3 This final rule will add new regulations…   Read more»

]]> d75f5678bce78064b2ebbccb97b0fd9a https://medicaldevicecourses.com/activity/p/25076/ Fri, 18 Mar 2022 15:32:45 -0400 Paradoxical as this idea and question seem to be if you take a moment to think about medical devices already on the market it is obvious medical doctors are innovators and developers of important medical devices. I am reminded of…   Read more»

]]> f966180b75b2aefdfd8fcb1080e06999 https://medicaldevicecourses.com/activity/p/25062/ Thu, 17 Mar 2022 17:03:54 -0400 Cost of Quality is the upfront cost for a guarantee in good faith practice for a product. The integrity of your brand is the reputation you have with your loyal customers. As a former quality lab technician for a food…   Read more»

]]> 817e67650d4a2653789ea8a244146d22 https://medicaldevicecourses.com/activity/p/24947/ Sun, 13 Mar 2022 00:45:09 -0500 @alexia-coffer you stated,  The three aspects of sustainability identified as “Triple Bottom Line,” or alternatively “Triple P: people, planet, and profit” show the balance or harmony between economic, social, and environmental aspects. These three pillars, however, are not stable but…   Read more»

]]> e225c2960e25d8cc6ccfeda0645c5c66 https://medicaldevicecourses.com/activity/p/24915/ Wed, 09 Mar 2022 21:08:46 -0500 From the perspective of the project manager facilitating the selection of a biomaterial is a crucial component to the overall success or failure of the project. The first point of contact would be with all key players on the project…   Read more»

]]> 546831c2e48ffa348322b14844538193 https://medicaldevicecourses.com/activity/p/24769/ Sat, 05 Mar 2022 03:05:21 -0500 @alexbryant-harden You highlighted a very important component in the medical devices industry is the competition. “Some other key differences are that when making medical devices, companies and teams go through other challenges with competitors and meet a specific deadline to…   Read more»

]]> 4e2e867062bd216bb5684d8762aeee42 https://medicaldevicecourses.com/activity/p/24768/ Sat, 05 Mar 2022 02:53:04 -0500 @takward You make a valid point about the budget and challenges of FDA approval. Do you think things will change at any point with the process of FDA approval in the area of medical devices as we have seen the…   Read more»

]]> dbcb5911f8078843f07e8a7c84427eff https://medicaldevicecourses.com/activity/p/24721/ Wed, 02 Mar 2022 16:10:35 -0500 Project management is a paradigm across all projects whether it incorporates every step at each level or not, the flow is similar overall.  There is a diagram that displays the flow of the project lifecycle and the steps of management….   Read more»

]]> 27039df8e5f09043f9fa39bed08ff34a https://medicaldevicecourses.com/activity/p/24707/ Tue, 01 Mar 2022 14:22:39 -0500 The medical device development field has numerous opportunities from the academic arena as well as the industry (Commercial) arena and one of them is better suited for specific personality types. The pros and cons of each are from the perception…   Read more»

]]> 30892a551a4caf6cfb0e2cc143173d05 https://medicaldevicecourses.com/activity/p/24691/ Mon, 28 Feb 2022 22:43:23 -0500 0