https://medicaldevicecourses.com/members/niya-j/activity/ Activity feed for niya-j. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 63016aff407a163039cc6611f05661b6 https://medicaldevicecourses.com/activity/p/22794/ Sun, 27 Jun 2021 21:39:48 -0400 @rowel2202 I think that is a fascinating perspective to take on organizational efficiency. I think the most effective organization is the one that allows the easiest communication routes and regulates the number of projects the staff has so the team…   Read more»

]]> 07f08eeb48298361d9faf39af1d2dae7 https://medicaldevicecourses.com/activity/p/22792/ Sun, 27 Jun 2021 21:34:30 -0400 I don’t have any experience working in any of the organization types at the moment. However, the format that seems the most appealing to me is the Matrix structure. I like the idea of picking which staff would best fit…   Read more»

]]> 77eaa4e5ef97beb361293348d3741f33 https://medicaldevicecourses.com/activity/p/22791/ Sun, 27 Jun 2021 21:26:57 -0400 Posted by: @la82 The lectures introduce the three types of organizations. Project managers’ roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference of working under one or the other, no one mentions what…   Read more»

]]> 0dc03fdb064e47bd1600b9fcb61c667d https://medicaldevicecourses.com/activity/p/22697/ Sun, 20 Jun 2021 03:47:23 -0400 Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or…   Read more»

]]> da5d075b2cc4cf81affbeb915675be09 https://medicaldevicecourses.com/activity/p/22696/ Sun, 20 Jun 2021 03:27:06 -0400 Risk management is the process of identifying, assessing, and eliminating potential hazards that develop while creating a product, in this case, a medical device. While risks are identified, they are documented and kept in a Risk Management Plan. Risks can…   Read more»

]]> 9493581bc11fb82a77f23f59b00c77f0 https://medicaldevicecourses.com/activity/p/22695/ Sun, 20 Jun 2021 03:14:57 -0400 Another benefit to PMS would be the continuous documentation of potential risks that may apply to similar devices or devices that aim to solve similar health issues. The monitoring of devices ensures that no other customers will experience any harm…   Read more»

]]> 5e8fcf7965424f621b29573b1f248ecf https://medicaldevicecourses.com/activity/p/22670/ Sun, 13 Jun 2021 23:08:34 -0400 The Communications management plan and the Scope management plan are the most important parts of the DDP, in my opinion. Determining the scope of a project sets the tone for the remainder of the design control and manufacturing process. It…   Read more»

]]> 45355335c7cf000cc1479cf192dbebf1 https://medicaldevicecourses.com/activity/p/22669/ Sun, 13 Jun 2021 22:57:29 -0400 The importance of taking minutes for meetings is not only to keep those who were not able to attend abreast of what is going on in the company but also to keep documentation f what is discussed during meetings and…   Read more»

]]> af4cd2781401792a2c7a175ea3bbbcc1 https://medicaldevicecourses.com/activity/p/22668/ Sun, 13 Jun 2021 22:50:51 -0400 Design controls are meant to not only plan out exactly what is required of the device for it to be functional once it hits the market, it serves the purpose of checking these plans multiple times to prevent mistakes in…   Read more»

]]> 2d1ce240b966deba86608abde6933125 https://medicaldevicecourses.com/activity/p/22604/ Sun, 06 Jun 2021 21:54:29 -0400 Posted by: @amd29 When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the…   Read more»

]]> 4941bfcdea8a684aa0c8814eab181fe9 https://medicaldevicecourses.com/activity/p/22603/ Sun, 06 Jun 2021 21:48:59 -0400 I can see both sides of this very controversial question. For the sake of ethics and basic human rights, I would support the enforcement of the Informed Consent Form if Henrietta had checked no for the research use of her…   Read more»

]]> 849b47ca98f2178de52c2d61972ad620 https://medicaldevicecourses.com/activity/p/22602/ Sun, 06 Jun 2021 21:41:58 -0400 I agree that a clinical background would be beneficial if you are pursuing an Investigator job. The experience of working with patients would help when communicating important information regarding the trial, and the science background would help Investigator translate the…   Read more»

]]> f1ec3ef06de57c368987cbbb464db193 https://medicaldevicecourses.com/activity/p/22560/ Sun, 30 May 2021 04:08:03 -0400 Some of the advertisements I have seen have been on Youtube. Still, they are “unskippable” and strategically placed in the middle of the video to prevent anyone from clicking away and keeps the viewer engaged because their desired content is…   Read more»

]]> 079bb096d0f38401789cfd5697202272 https://medicaldevicecourses.com/activity/p/22559/ Sun, 30 May 2021 02:08:36 -0400 I think the most creative recent advertisement was for Match.com. With the assistance of Ryan Reynolds, The company had advertised its “perfect match” algorithm by matching Satan himself with the year 2020. It brought together the collective horrible feeling that…   Read more»

]]> 2202671f1ad2ec378d58d1f124acb442 https://medicaldevicecourses.com/activity/p/22558/ Sun, 30 May 2021 01:36:06 -0400 Ive noticed that most technology commercials, specifically new phone commercials, usually use an all-black or all-white background to draw focus to the product. The color white in advertising reflects cleanliness or simplicity, and those white backgrounds are mostly paired with…   Read more»

]]> b3dcc519a61c8bcdaae0e94efeda49c5 https://medicaldevicecourses.com/activity/p/22514/ Sat, 22 May 2021 21:52:55 -0400 I do not think the FD ai s being too strict in their regulations. Their goal is to keep the general public safe from any harm from drugs, medical devices, and food. If they weren’t as strict as they are,…   Read more»

]]> c2bc2be2ae3a93bde97ab1609f1a3fc1 https://medicaldevicecourses.com/activity/p/22513/ Sat, 22 May 2021 21:42:13 -0400 Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

]]> 1079f4f3dc6ce5a2d7c947d2c81b384b https://medicaldevicecourses.com/activity/p/22512/ Sat, 22 May 2021 21:17:59 -0400 Posted by: @mduru As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have…   Read more»

]]> e5f5c48b6e147a72c46ada59b184fbb2 https://medicaldevicecourses.com/activity/p/22469/ Sun, 16 May 2021 04:52:31 -0400 Animal models are essential when attempting to see the effects of medical devices in a live system. I acknowledge that the taking of animal life may be unethical in a setting without procedures, but done in a lab where the…   Read more»

]]> e7800931bffcdb5f2e47a5e2918d619d https://medicaldevicecourses.com/activity/p/22468/ Sun, 16 May 2021 04:39:27 -0400 Both areas of research are essential for different reasons. Researching the present can be compared to what has been done for the recent COVID-19 pandemic. Rigorous research was being done to understand the virus and treat it in a short…   Read more»

]]> e997e3a4725aec5e44b8942dd075f2ee https://medicaldevicecourses.com/activity/p/22467/ Sun, 16 May 2021 04:24:59 -0400 I believe a dialog between the two parties is the best solution to prevent any incidents like the destruction of research. It may benefit from having a member of these organizations on research pannels to provide some insight on potential…   Read more»

]]> 01f1c91aaf6a1bc740644d010c855011 https://medicaldevicecourses.com/activity/p/22440/ Mon, 10 May 2021 02:21:48 -0400 I agree with the idea of “more education=higher position,” but sometimes that’s not the case. The more I ask about careers in this field, the more I hear about the connections that helped many people get into today’s positions. I…   Read more»

]]> 3f7838108f23e2ec9aedb5360ea6fa99 https://medicaldevicecourses.com/activity/p/22437/ Mon, 10 May 2021 01:51:32 -0400 At the time of this post, we are still dealing with e after-effects of COVID-19’s impact on the medical field. Thankfully, most manufacturers have bounced back and can produce more essentials to keep the general public safe, like N95 masks,…   Read more»

]]> b1b3ec23aa593da6745d3bb0934e64ac https://medicaldevicecourses.com/activity/p/22436/ Mon, 10 May 2021 01:41:16 -0400 Academia relies on grants and academic personnel like student volunteers or other professors to continue their projects, and there is lower pay compared to industry jobs. However, the freedom of conducting your own experiments and traveling without much of a…   Read more»

]]> 8642e16daac08e3b3470b897060c8a1d https://medicaldevicecourses.com/activity/p/22300/ Mon, 26 Apr 2021 01:30:32 -0400 Posted by: @devarshi-joshi The main functions of Human Resource Management department are : 1) Reduce turnover 2)Hire for fit 3)Focus on retention of top performers 5)Improve employee engagement. So my question is how this will help in medical field improving…   Read more»

]]> ead39aa425a77254b96801b6fb38b4e9 https://medicaldevicecourses.com/activity/p/22297/ Mon, 26 Apr 2021 01:16:32 -0400 1. I believe the PM should be in charge of developing communication and delegating who is in charge of distributing specific information to task teams. The PM should also consider the need for clarity and detail when communicating many things…   Read more»

]]> 71d6aa1069f1886d7e8b78699d5d7c96 https://medicaldevicecourses.com/activity/p/22295/ Mon, 26 Apr 2021 00:44:22 -0400 Quality assurance deals with setting and perfecting metrics for quality control to following and determining whether these metrics align with the overall Quality Management Plan. In contrast, quality control is the act of checking/ measuring the deliverables and seeing if…   Read more»

]]> 975fb2617213d869a7e6758a76598ece https://medicaldevicecourses.com/activity/p/22195/ Mon, 19 Apr 2021 03:56:01 -0400 When evaluating a change request, the monitor and control team should consider the nature of the change and the long-term effects of this change if it were to be approved. Would the change benefit the patient if it is a…   Read more»

]]> 19c7f768348908b7250a201cae0b3a2b https://medicaldevicecourses.com/activity/p/22189/ Mon, 19 Apr 2021 03:32:19 -0400 The execution portion of a project should have days planned into the schedule to consider the vacation time of the team members. The project schedule can use some of this “cushion” of time in conjunction with project lag time just…   Read more»

]]> 863151857ac1f4add7291613c05d1c8a https://medicaldevicecourses.com/activity/p/22184/ Mon, 19 Apr 2021 03:19:17 -0400 Some reasons for a budget increase on a project may include an inefficient initial design of a medical device that requires necessary revisions. Going backward and redesign an entire product for whatever reason will inevitably increase the budget. Backtracking on…   Read more»

]]> f7b2abed637acb323fbbfb62693e4a24 https://medicaldevicecourses.com/activity/p/22069/ Mon, 12 Apr 2021 02:37:35 -0400 Posted by: @rjs84 Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing…   Read more»

]]> d4777a579dccb2933a121b24f655fc28 https://medicaldevicecourses.com/activity/p/22066/ Mon, 12 Apr 2021 02:04:09 -0400 This has absolutely been ad huge benefit to my understanding of how biotechnology is produced and processed. Taking Dr. Simon’s accelerated PM course over the summer gave me a good general overview of the PM processes and how they can…   Read more»

]]> 7c3ca0601379b37fb7de57a959d27462 https://medicaldevicecourses.com/activity/p/22065/ Mon, 12 Apr 2021 01:38:34 -0400 The overlapping activities throughout the Gantt chart represent the project as a whole. There may be several tasks taking place simultaneously, and visualizing this on a Gantt chart may help keep tasks on schedule. Some tasks have varying durations and…   Read more»

]]> 395ceae7d1f5f4952faf9339a006272d https://medicaldevicecourses.com/activity/p/21986/ Mon, 05 Apr 2021 03:30:00 -0400 The only way for a PM to communicate to unresponsive members of a team, or members with clashing schedules, is to make the necessary information readily available in a communication forum. This forum could be an email, it could be…   Read more»

]]> ba90c0b0b814def1ad0adcb3549e461b https://medicaldevicecourses.com/activity/p/21985/ Mon, 05 Apr 2021 03:22:04 -0400 @k-faulk You raised some good points in your response. I think the team as a whole, or at least the tasks managers and the PM, should come together to see which completed and future tasks can connect given the missing…   Read more»

]]> 7dde66144bdc1b9f8389e6118b159908 https://medicaldevicecourses.com/activity/p/21983/ Mon, 05 Apr 2021 03:14:56 -0400 The consensus of the team is critical when the motivation of the project team is taken into consideration. If the team doesn’t feel motivated to continue the project because they disagree with the scope or direction, the outcome won’t be…   Read more»

]]> 480a1b7883ef67c7d916921d5fb43f25 https://medicaldevicecourses.com/activity/p/21929/ Mon, 29 Mar 2021 03:12:02 -0400 The closing phase involves closing out contracts with outsourced resources for legal documentation and proof of service. After the contracts are closed and the project is deemed finished, the team needs to be paid. The PM then writes a final…   Read more»

]]> d1cf54ebb613f9680f15f598231c443b https://medicaldevicecourses.com/activity/p/21928/ Mon, 29 Mar 2021 03:05:08 -0400 A project cannot be implemented if there is no team to execute the plan. In the given scenario, I believe it is worth it to revisit the initial plan to have the project be successful and completed in a relatively…   Read more»

]]> 9b2f15ea2302a0cfa70c7a856ca4e223 https://medicaldevicecourses.com/activity/p/21922/ Mon, 29 Mar 2021 02:35:27 -0400 The failure of a project can be found in either the planning or execution phases. Poor planning of a project can be found in employment choices for the team, a timeline that hasn’t made room for mistakes or delays in…   Read more»

]]> 36eeed5049057dcb80ca97397badcfe9 https://medicaldevicecourses.com/activity/p/21837/ Mon, 22 Mar 2021 02:43:01 -0400 I think the area of overlap can be found in the Product life cycle’s developmental phase. During this time, the Project is being conceived, and the Project manager is going through the Initiating and Planning phase. As the Product life…   Read more»

]]> 3aaca9f08099acbfc7e246c5ae861beb https://medicaldevicecourses.com/activity/p/21836/ Mon, 22 Mar 2021 02:26:35 -0400 If safety information on a label is coming off of the product, there is absolutely a need to recall if the fault is the initial adhesive applied by the company. Information that addresses the safe use of a product is…   Read more»

]]> d2e1621768ad6fbd6c06117bd9fe5721 https://medicaldevicecourses.com/activity/p/21834/ Mon, 22 Mar 2021 02:08:03 -0400 The pros and cons of each functional group are as follows: Functional organization advantages include having the managers hold power when making major decisions, a direct line for communication within the silos, and a defined position for those in the…   Read more»

]]> 7892062ef4ffc84d14e2fce90e0c1414 https://medicaldevicecourses.com/activity/p/21771/ Mon, 15 Mar 2021 03:10:58 -0400 In the case of a combination device, the FDA would look at the Primary Mode of Action. Once determined, the device will be assigned to one of the three agencies: CBER, CDRH, and CDER. After the device is assigned, it…   Read more»

]]> d40d6fe85913fff00032f7a0334b3e0e https://medicaldevicecourses.com/activity/p/21767/ Mon, 15 Mar 2021 02:35:16 -0400 Critical thinking is an underrated skill applicable to a Project Management position and everyday life. This skill allows you to make nonreactionary, unbiased decisions when problems arise in the workplace. Several things can go wrong during projects, and they may…   Read more»

]]> 140226e63e569e0fd53c4f8fae5e0e2f https://medicaldevicecourses.com/activity/p/21756/ Mon, 15 Mar 2021 01:57:48 -0400 I think the education system for more technical careers is a bit backward, but I don’t want to diminish the value of interpersonal skills in a technical setting. Speaking from personal experience, I was taught several facts about biological systems…   Read more»

]]> e66673bccb7a5bacb5be069c0107f55f https://medicaldevicecourses.com/activity/p/21679/ Sat, 13 Mar 2021 23:44:46 -0500 @llefevre That is a wonderful way to compile all the necessary elements of emotional intelligence. Recognition, understanding, reasoning, and management are all needed for effective communication within the project team. A breakdown of communication within a project can be the…   Read more»

]]> 2d3a029c563dc42d64cd354aa4cc8f40 https://medicaldevicecourses.com/activity/p/21678/ Sat, 13 Mar 2021 23:44:45 -0500 In an ideal project team, you would have diverse experts relative to the project at hand. As Roberto said, if you have a product that requires electrical expertise, you would have electricians complete the job. If you worked on a…   Read more»

]]> 8a3621420e6f676a69c9073474bc46ec https://medicaldevicecourses.com/activity/p/21677/ Sat, 13 Mar 2021 23:44:45 -0500 I think it’s sad but inevitable for some projects to be put at a lower priority than others or even retired for whatever reason. All projects consist of a team that has put in work to make the result possible….   Read more»

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