https://medicaldevicecourses.com/members/an83/activity/ Activity feed for an83. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 384176b9b28ccf2ae69854c1b71e5822 https://medicaldevicecourses.com/activity/p/28602/ Mon, 04 Dec 2023 04:28:34 -0500 In considering the viability of consulting as a career path for recent graduates, it’s important to weigh the unique advantages and considerations it presents, especially in a competitive job market. Consulting offers flexibility, diverse learning opportunities, and potential pathways to…   Read more»

]]> ff23ed96314c9cb1731028ebd3e03f38 https://medicaldevicecourses.com/activity/p/28601/ Mon, 04 Dec 2023 04:25:08 -0500 The ethical guidelines governing gifts and incentives in the medical industry, particularly the $100 cap on gifts to physicians and the prohibition of covering expenses for a physician’s spouse, may initially appear overly restrictive. However, these rules serve a vital…   Read more»

]]> 52ffabe2378fd3c62efea67f68fa1e4e https://medicaldevicecourses.com/activity/p/28600/ Mon, 04 Dec 2023 04:20:17 -0500 In the medical device industry, ensuring adherence to verbal contracts involves a combination of meticulous documentation and ethical practices. One key strategy is the detailed recording of conversations, where notes are taken during or right after discussions; however, if actual…   Read more»

]]> 95a4c47a06d2db2816d3b36e9829f3c4 https://medicaldevicecourses.com/activity/p/28546/ Mon, 27 Nov 2023 03:04:19 -0500 I really like your analogy to Maslow’s Hierarchy of Needs. In the responses so far, there seems to be a divergence between the needs of the company and the needs of the employees. There seems to be good discussion addressing…   Read more»

]]> bf5d1d3bcbc11a7bae56d4dc2c5c7fd7 https://medicaldevicecourses.com/activity/p/28545/ Mon, 27 Nov 2023 02:43:31 -0500 There are pros and cons to working with those familiar to you. One pro is that the forming and storming phases of project team formation are much more streamlined, especially if one is familiar with the working styles of other…   Read more»

]]> 0b8e165f5aa94a7a4ddd17409af30a2a https://medicaldevicecourses.com/activity/p/28544/ Mon, 27 Nov 2023 02:14:00 -0500 To see the pros in decisions made by one person is an interesting concept. In school, especially in the American standard of education, we are taught, both in the form of group projects and 20th century history lessons, that decisions…   Read more»

]]> 30a19b7050aa361fb1cbc63f6cc896a9 https://medicaldevicecourses.com/activity/p/28509/ Mon, 20 Nov 2023 04:21:44 -0500 Your observations about the costs associated with accessing various standards and regulations in the medical device market are indeed thought-provoking. The primary reason these regulations carry a significant cost is that regulatory compliance has evolved into a complex and specialized…   Read more»

]]> ac075efb5559cd120cea1d580c8a2494 https://medicaldevicecourses.com/activity/p/28508/ Mon, 20 Nov 2023 04:10:33 -0500 Risk management is an essential part of the planning phase, embodying the principle that “a stitch in time saves nine.” By identifying and addressing potential risks early, it prevents minor issues from escalating into major setbacks, thereby saving time and…   Read more»

]]> 82829517680a82e8ddf305cf6f491b14 https://medicaldevicecourses.com/activity/p/28507/ Mon, 20 Nov 2023 04:04:58 -0500 Risk acceptance does indeed imply a higher probability of encountering the risk, as it involves acknowledging the risk without taking any specific action to avoid or mitigate it. This approach is typically chosen when the cost or effort of other…   Read more»

]]> 8cf37cf98a2687065bf056c7a53984ad https://medicaldevicecourses.com/activity/p/28448/ Mon, 13 Nov 2023 03:40:19 -0500 A basic overview of the design process may be obtained from a Design Matrix that includes columns for inputs, requirements, validation, and verification; however, for more complicated projects, this may not be sufficient. Its effectiveness may be significantly increased by…   Read more»

]]> 914a147b2a37155b82f352b326dcfa1f https://medicaldevicecourses.com/activity/p/28447/ Mon, 13 Nov 2023 03:36:52 -0500 When creating a Gantt chart for project management, start by defining the project scope and objectives to identify all necessary tasks. Break the project into smaller tasks, and establish their sequence and dependencies, recognizing which tasks are sequential and which…   Read more»

]]> f07f50a1cb1a07373bd95748fa17f3bd https://medicaldevicecourses.com/activity/p/28446/ Mon, 13 Nov 2023 03:33:39 -0500 Issuing a Design Change Request is the normal remedial action when problems are found in design documents, such as the Design Input Document (DID) or the Design Specification Document (DSD). This procedure starts with locating the mistake and ends with…   Read more»

]]> 2fc57aafb9ee8feba8536b93328cbe7f https://medicaldevicecourses.com/activity/p/28392/ Tue, 07 Nov 2023 03:00:53 -0500 Meeting minutes are an essential tool for effective team communication, serving as a detailed record that enhances accountability, provides clarity, ensures continuity, and meets legal requirements. They not only capture decisions and assignments, fostering accountability, but also act as a…   Read more»

]]> 4c914ac7e54aa7cfc23d2ff67a57c4c7 https://medicaldevicecourses.com/activity/p/28391/ Tue, 07 Nov 2023 02:58:41 -0500 In product development, verification and validation serve as critical, distinct checkpoints to ensure quality and efficacy. Verification addresses the question, “Are we building the product right?” by confirming that the product adheres to specific design requirements through tests, inspections, and…   Read more»

]]> f30c4c2d785f8fc0ac5b39514eea844a https://medicaldevicecourses.com/activity/p/28390/ Tue, 07 Nov 2023 02:57:06 -0500 Implementing a robust Risk Management Process is paramount when redesigning design controls in a medical device company, as it ensures compliance with regulations like ISO 14971 and fortifies the Quality Management System. This process, which is integral to product safety…   Read more»

]]> 7e2a9dfe3ae74e617bdf70fa55fbd5d3 https://medicaldevicecourses.com/activity/p/28317/ Sun, 29 Oct 2023 20:12:15 -0400 Honestly, money seems to be the greatest form of financial compensation that could be offered. Many people above have suggested offering healthcare services; however, in the United States, that is functionally equivalent to financial compensation, which would likely go towards…   Read more»

]]> fa59cab521fa2f85db8dbf6047617b71 https://medicaldevicecourses.com/activity/p/28316/ Sun, 29 Oct 2023 20:04:41 -0400 My aim is to look into the applications of artificial intelligence in radiology. Therefore, for my career path, the best type of clinical study would undoubtedly be a Retrospective Study. Radiology, as a field, has amassed a vast amount of…   Read more»

]]> 26d49530ac6cf49cf9be4f14694412c9 https://medicaldevicecourses.com/activity/p/28315/ Sun, 29 Oct 2023 19:47:12 -0400 I would disagree that the placebo effect can have negative effects on a clinical trial. This is because in a clinical trial, there is a difference between a sign and a symptom. Signs are results of illness that are visible…   Read more»

]]> f7fac6a1a8f2474619f509e408b08c82 https://medicaldevicecourses.com/activity/p/28283/ Mon, 23 Oct 2023 03:28:46 -0400 From my perspective, while I don’t have a background in journalism or creating media content, I’ve observed the trends in marketing and advertising across various channels. It’s evident that companies, especially in the biotechnology and medical device sectors, strategically place…   Read more»

]]> 0df5c79a0324ebb43f0d39567c44c080 https://medicaldevicecourses.com/activity/p/28280/ Mon, 23 Oct 2023 03:20:43 -0400 Engineering majors follow the opposite trend of communications majors. While communications majors are most hireable right after they finish college, engineering majors are most valuable after years of experience. However, that experience is not always directly transferable after years of…   Read more»

]]> 4558f65ae6ddedad49ca0be531675846 https://medicaldevicecourses.com/activity/p/28278/ Mon, 23 Oct 2023 03:13:47 -0400 I do not believe a business minor/major is too useful for an aspiring engineering major. This is because my belief is that an undergraduate education only prepares someone for the immediate next steps, which would either be graduate school or…   Read more»

]]> 01b854bb07d6131017bf323dd1d44c7f https://medicaldevicecourses.com/activity/p/28220/ Sun, 15 Oct 2023 23:18:44 -0400 After delving into the intricacies of various company types from this week’s lecture, I’ve come to realize the importance of the organizational structure in influencing my decision to accept a job offer. While many prioritize researching a company’s financial health,…   Read more»

]]> 2968ec38557cda8adf6d0a53407339ff https://medicaldevicecourses.com/activity/p/28219/ Sun, 15 Oct 2023 23:08:42 -0400 Different financial ratios can be used to assess various aspects of a company’s health, as was explained in Dr. Simon’s presentation. The size and reputation of the organization in question can affect how important each ratio is. Investors and analysts…   Read more»

]]> e1b00230d705aa39d1145c1de0534b81 https://medicaldevicecourses.com/activity/p/28218/ Sun, 15 Oct 2023 23:04:00 -0400 As an NJIT grad, I agree that engineering students should be required to take additional engineering courses. The problem with the way the current BME curriculum is laid out is that their is not much room for engineering courses. Besides…   Read more»

]]> 161bf3d3b6659d7c22a19764d857d99b https://medicaldevicecourses.com/activity/p/28094/ Sun, 01 Oct 2023 15:21:30 -0400 In the realm of medical device projects, both Quality Control (QC) and Quality Assurance (QA) play pivotal roles. QC, being product-oriented, predominantly involves inspections of the product’s quality, ensuring that results align with expectations. It primarily dwells in the domain…   Read more»

]]> c8b2ce94d42f7eed666c0214e11a1e29 https://medicaldevicecourses.com/activity/p/28093/ Sun, 01 Oct 2023 15:12:16 -0400 Quality Assurance (QA) and Quality Control (QC) are integral components of product quality management, though they approach it from different angles. At its core, QA is proactive, emphasizing the prevention of defects by establishing robust processes and systems. It sets…   Read more»

]]> 1f9838d440ee9ee468498fc7ca870d1c https://medicaldevicecourses.com/activity/p/28090/ Sun, 01 Oct 2023 15:00:24 -0400 Quality management systems (QMS) are fundamental to ensuring that products and services meet specified requirements and standards. Within the QMS, there are various roles spanning from low to high levels, each dedicated to ensuring and controlling quality. For instance, a…   Read more»

]]> 79593772dfed9654f20f702edbdc3513 https://medicaldevicecourses.com/activity/p/28059/ Wed, 27 Sep 2023 20:02:13 -0400 As mentioned by multiple people above, close to 100% transparency is required. However, I do not necessarily agree that transparency is requried in the pre-clinical phases of product development; only the trials of the released prototype should be made public….   Read more»

]]> 05387a1de449be48c4ad906dc1f7d77e https://medicaldevicecourses.com/activity/p/28058/ Wed, 27 Sep 2023 19:52:43 -0400 What is most important to address is that most physicians, while possessing an exceeding amount of knowledge in clinical practice, which may inspire their development of a medical device, they often lack the technical expertise necessary to create a medical…   Read more»

]]> 5d4ab0fa4a89956debaf1d8537c944fa https://medicaldevicecourses.com/activity/p/28042/ Mon, 25 Sep 2023 21:02:48 -0400 In no way are FDA rules too strict. Although many manufacturers and pharmaceutical suppliers may face difficulty in bring thir products to market, this ensures that the medical products released to the market cannot cause undue harm to members of…   Read more»

]]> 4c25c33b8839ceb96a8fc5d73acfd6c2 https://medicaldevicecourses.com/activity/p/28031/ Sun, 24 Sep 2023 23:43:55 -0400 From my experience, most research professors who teach are less interested in teaching, and it shows in the courses they conduct. On one hand, you have the professors who make the class unnecessarily easy, offering limited help to students if…   Read more»

]]> 047f501f5a3062bcfdfeb1e1e855728e https://medicaldevicecourses.com/activity/p/28030/ Sun, 24 Sep 2023 23:33:28 -0400 This is definitely a matter up to personal preference, but personally, I would rather work for the present. While I do understand the appeal of working for the future, I personally believe that the best advances happen in steps that…   Read more»

]]> 703d1842303e58a885e83861e1b18bdd https://medicaldevicecourses.com/activity/p/28028/ Sun, 24 Sep 2023 23:25:38 -0400 To start out, both academia and industry require a great deal of knowledge from their employees. It may not be fair to say that academics always possess greater knowledge than people in industry simply because they may use their education…   Read more»

]]> f5fd8c868bff4fa3fe0804a896b33a84 https://medicaldevicecourses.com/activity/p/27919/ Mon, 11 Sep 2023 18:09:48 -0400 The initiating phase is the most important phase of the project life cycle. As this is a medical device course forum, it feels slightly appropos to use a biological analogy. In order for a cell to replicate in mitosis, it…   Read more»

]]> d50a6ce42885c9b04b635ca97cf529ae https://medicaldevicecourses.com/activity/p/27918/ Mon, 11 Sep 2023 17:56:46 -0400 There is nothing inherently wrong with being an overachiever, unless the ambition interferes with the completion of the basic requirements of the project. This is often the primary factor that leads to scope creep. Therefore, the main way to avoid…   Read more»

]]> 2980b3e3977e583085432daf923d9c03 https://medicaldevicecourses.com/activity/p/27917/ Mon, 11 Sep 2023 17:45:10 -0400 AI can be a very effective tool in project management; however, as the two users above mentioned, it should not be used without the supervision of a human. One way which AI can help project management is by streamlining mundane,…   Read more»

]]> f0fa7d20a21fec0f35ea2f6e6432aa0c https://medicaldevicecourses.com/activity/p/27870/ Sat, 09 Sep 2023 18:42:59 -0400 While I agree that grades may not necessarily reflect the ability of one to perform a job to completion, grades still do appear to reflect the amount of effort one is willing to place upon a project. For this reason,…   Read more»

]]> bdea75c77d5606dd13dd99303ed9bf9e https://medicaldevicecourses.com/activity/p/27869/ Sat, 09 Sep 2023 18:42:58 -0400 @jj52 Although I agree with your premise, I must slightly disagree with one specific point you made. Most of your premise is built around the assumption that after people with “C’s get degrees”, their grades will never again matter in…   Read more»

]]> a2dd53aaed0ce65161079e416bf3bc2c https://medicaldevicecourses.com/activity/p/27868/ Sat, 09 Sep 2023 18:42:55 -0400 As I’m writing this, it has been two years since the world returned to a sense of “normalcy” following the pandemic. I was actually in high school between March 2020-June 2021, experiencing what I like to call “senioritis to the…   Read more»

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