https://medicaldevicecourses.com/members/ap499/activity/ Activity feed for ap499. Fri, 01 May 2026 17:52:07 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e91ec82404fba797c44e4fda83ff282e https://medicaldevicecourses.com/activity/p/18332/ Wed, 15 May 2019 21:47:23 -0400 As it is defined, Non-Conformance Material Report (NCMR) allows an individual to report non-conforming material identified during an inspection of items or material or during the movement of the materials. The purpose of the nonconforming material process is to ensure…   Read more»

]]> 5c08e492fd308c0154008944db751049 https://medicaldevicecourses.com/activity/p/18325/ Wed, 15 May 2019 21:47:18 -0400 For an individual to leave work, there could be multiple reasons. One of the many reasons could be not receiving recognition for the work delivered. Being recognized by your superior for the outstanding work you deliver is as important to…   Read more»

]]> 31be510dac921113b61b626a33775172 https://medicaldevicecourses.com/activity/p/18324/ Wed, 15 May 2019 21:47:18 -0400 Similar to many of my fellow may have already mentioned, this class provides very valuable knowledge. It doesn’t only teach one the broad topic on project management in the medical field but it also taught how one should respond to…   Read more»

]]> cf9c67471d01b7e4d2f68e21f82ad220 https://medicaldevicecourses.com/activity/p/18238/ Wed, 15 May 2019 21:46:35 -0400 In my opinion, this issue is quite common in the workplace. It occurs due to the lack of leadership role from the upper management end. Workers have their projects and reports given to their superior management. From there, it is…   Read more»

]]> 214edb766cd886b86d325a97f2201b47 https://medicaldevicecourses.com/activity/p/18237/ Wed, 15 May 2019 21:46:35 -0400 Many of the things that motivate others are similar to what motivates me. Taking up challenges and surviving those challenges to feel satisfied in my work motivates me to continue further. The satisfaction feel is one thing that one cannot…   Read more»

]]> 06a4bc2b336c19e667f7e3e2651d594a https://medicaldevicecourses.com/activity/p/18236/ Wed, 15 May 2019 21:46:34 -0400 The study results did not surprise me much, to be honest. In my opinion, most of the people work for the money, to gain the lifestyle they desire. Everyone needs money in order to survive in this world. Whether it…   Read more»

]]> 090537939778cf397ad1f4b9732ce947 https://medicaldevicecourses.com/activity/p/18159/ Wed, 15 May 2019 21:45:53 -0400 In my opinion, Schedule variance should be positive and cost variance negative is better if one situation has to be choose between two given. When schedule variance is positive, it is beneficial for the project because the project is progressing…   Read more»

]]> 0cc849273ef2f3781f0f4d4e05c21fca https://medicaldevicecourses.com/activity/p/18157/ Wed, 15 May 2019 21:45:52 -0400 Planned value is the value of the work which we are supposed to have on the deadline date. While the actual cost is what the task actually finish up costing when the project completes. These both values are an important…   Read more»

]]> d0f7c94b2be476ce38e83ffd04963b85 https://medicaldevicecourses.com/activity/p/18154/ Wed, 15 May 2019 21:45:50 -0400 I agree that the Project Planning Phase is extremely important and crucial for any project’s success. A project must be planned well. Planning is required as it helps in identifying the desired goals, reducing the risks, avoiding the deadlines, and…   Read more»

]]> 88f297ca5faf1c6c9393310e1fbcac77 https://medicaldevicecourses.com/activity/p/18085/ Wed, 15 May 2019 21:45:16 -0400 The phrase – “Everything is about risk” means that the entire project is dependent on whether the reward of continuing the project will outweigh the risk. A project manager must analyze all the possible options and their outcomes before taking…   Read more»

]]> d28c5d4a8adbed5e2d00c5cca8781689 https://medicaldevicecourses.com/activity/p/18077/ Wed, 15 May 2019 21:45:13 -0400 For effective project management, accurate time estimation is crucial. The team member and their logs must be updated at each and every milestone for clarity and proper completion of the project. In order to achieve that goal, all team members…   Read more»

]]> d09d9e661aa7927ab72806afb7751799 https://medicaldevicecourses.com/activity/p/18076/ Wed, 15 May 2019 21:45:12 -0400 As you have mentioned, Schedule variance specifies project whether how much ahead or behind the schedule. Some factors that can affect the project schedule variance are unexpected changes to the design of the project. These changes bring the new request…   Read more»

]]> bc49b746fc16b78bb8d0936960fe480b https://medicaldevicecourses.com/activity/p/18021/ Wed, 15 May 2019 21:44:41 -0400 Logging work is the most important phase in the project or either in work place. For me, keeping a detailed log of work helps you to produce an intended result in any projects by keeping track of what you have…   Read more»

]]> ce9c15853ebc2f0b475b3a1d00f885a7 https://medicaldevicecourses.com/activity/p/18019/ Wed, 15 May 2019 21:44:40 -0400 In the medical field, one should expect that there will always be success and failure. It is the competitive field dealing with human beings and finding a solution to peoples problems. Therefore, it is important that one should always have…   Read more»

]]> b57f6a016ab614ac8db97b3becd222c1 https://medicaldevicecourses.com/activity/p/18018/ Wed, 15 May 2019 21:44:39 -0400 It is already half of the semester, and till now we have been studying all different methods and documents that support in managing the project. According to me, the best way to meet the deadlines in this scenario is to…   Read more»

]]> 9d374c36a8dad1525495ed6c3b3acd5d https://medicaldevicecourses.com/activity/p/17927/ Wed, 15 May 2019 21:43:55 -0400 As @mb698 have mentioned, every phase is important in project management however, initiating the project, planning on how to divide into segments and executing that plan is the most crucial part of a project. These are an important phase as…   Read more»

]]> e16a660591330de3fb6244e49c7edf41 https://medicaldevicecourses.com/activity/p/17925/ Wed, 15 May 2019 21:43:54 -0400 Design Validation is a powerful tool to achieve a highly effective product. For medical devices, it is crucial to conduct a human factor study to be precisely making sure that the device, equipment or process fits well to the human…   Read more»

]]> dbe6a3b4908ce5986f121d3cf0a93eac https://medicaldevicecourses.com/activity/p/17923/ Wed, 15 May 2019 21:43:53 -0400 According to me, logging at work has proven to be very effective and save the struggle when any issue occurs. For me, keeping a detailed log of work helps you to produce an intended result in any projects by keeping…   Read more»

]]> cb475a5550f87d2326b3fbd785032e2a https://medicaldevicecourses.com/activity/p/17845/ Wed, 15 May 2019 21:43:12 -0400 For any project to succeed does not matter what field it is from, communication and collaboration is the key. It is every team members responsibility to inform the project manager of their possible holiday/vacation time. Based on that, the manager…   Read more»

]]> dbc0b7fe03bf39f034848c0da64f5764 https://medicaldevicecourses.com/activity/p/17844/ Wed, 15 May 2019 21:43:12 -0400 In the field of project management, things do go wrong and unexpected changes are always there. So, including a time buffer as a line item in the schedule is a way to account for unknown changes in the schedule. Also,…   Read more»

]]> 55fc213226b48275a9fcc28f8658b344 https://medicaldevicecourses.com/activity/p/17843/ Wed, 15 May 2019 21:43:11 -0400 According to me, every milestone is important for any project. Therefore, any missed milestone will have an impact on a project. The only difference is whether the missed milestone falls under either of these two categories: major or minor. Minor…   Read more»

]]> 4a7e99d985b05a6b139dc626aace1506 https://medicaldevicecourses.com/activity/p/17732/ Wed, 15 May 2019 21:42:10 -0400 Design input document states what the product objective and its purpose. Besides the marketing team compiling the document, the whole team, sponsor, and customers also give their input, since the Design input document gives the necessary desires for the products…   Read more»

]]> 210dac3da11810e265b9fe3454d4daae https://medicaldevicecourses.com/activity/p/17731/ Wed, 15 May 2019 21:42:10 -0400 According to me, to help track the status of the project, one must establish goals and milestone and in order to keep track of this milestone, the manager must hold team minute meetings which provides detail on the project with…   Read more»

]]> aba97be07a3ae42059be7bd9e95e365e https://medicaldevicecourses.com/activity/p/17730/ Wed, 15 May 2019 21:42:09 -0400 As you have mentioned already, combination products are combined drugs, devices, and/or biological products with one another, and are a growing and important category of therapeutic and diagnostic products. Similar to medical devices classification, combination products are also classified into…   Read more»

]]> 87f631068ad514d92a439620850e1138 https://medicaldevicecourses.com/activity/p/17729/ Wed, 15 May 2019 21:42:09 -0400 When it comes to an ideal project team, I believe the project manager must choose the project and its team members wisely. In order to have a successful project, it requires a sponsor, whose project the team is going to…   Read more»

]]> 6b036b978e624da2710b541ff7b2b0c0 https://medicaldevicecourses.com/activity/p/17727/ Wed, 15 May 2019 21:42:08 -0400 In my opinion, I don’t think it is necessary to have a separate classification for the device as the function of the device is already known in the market or FDA database. If the FDA finds the devices with more…   Read more»

]]> 773ba64ae662e07eba2534042aa8a257 https://medicaldevicecourses.com/activity/p/17725/ Wed, 15 May 2019 21:42:07 -0400 Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. In order to have a proper meeting for the design review and a project to move as swiftly…   Read more»

]]> 5600ef3f14092785aea2329aff9ae705 https://medicaldevicecourses.com/activity/p/17610/ Wed, 15 May 2019 21:41:02 -0400 The core of the successful project manager revolved around the interactions of the team and their communications. As a project manager, one needs to communicate with everyone from a team member, to different departments, to physicians, to hospitals administration in…   Read more»

]]> ea00edb59dccebe64c5365e279e49099 https://medicaldevicecourses.com/activity/p/17609/ Wed, 15 May 2019 21:41:01 -0400 I believe in order to use an unapproved device, Physician’s must understand their role and responsibilities. And also understand when an emergency is to use an unapproved device. For a situation to be an emergency, there must be a life-threatening…   Read more»

]]> 943734dd762a7e5ee297e222481169f2 https://medicaldevicecourses.com/activity/p/17606/ Wed, 15 May 2019 21:41:00 -0400 Once a product is in the market for the public to use, any unpredictable problems can lead to a recall. However, recalls are always voluntary. Sometimes a company discovers a problem and recalls a product on its own without consulting…   Read more»

]]> 5c2bee11278dd073c149eb8de7e0d180 https://medicaldevicecourses.com/activity/p/17562/ Wed, 15 May 2019 21:40:39 -0400 For every medical device, whether it involves risk or not, it needs to be regulated by FDA. And the center that regulates the medical devices is CDRH which is the Center for Devices and Radiological Health. They review and approves…   Read more»

]]> c423621fa99b4bb565d80e2a03bc85bb https://medicaldevicecourses.com/activity/p/17561/ Wed, 15 May 2019 21:40:38 -0400 A risk management plan is a crucial step in a project. It helps to identify risks and implement a plan to reduce them. It helps the members to foresee risks, identify actions to prevent them from occurring and reducing their…   Read more»

]]> 87bb34a49d21e78735385d38d96db35b https://medicaldevicecourses.com/activity/p/17559/ Wed, 15 May 2019 21:40:37 -0400 I think quality planning is a critical part of any project in the medical field. It allows an individual to agree on a set of quality targets with your customer. A quality plan helps you to schedule all of the…   Read more»

]]> eefc6fed75a54fd4b6255690ea20be5b https://medicaldevicecourses.com/activity/p/17401/ Wed, 15 May 2019 21:39:10 -0400 Certain companies ask an employee to sign an NDA (non-disclosure agreement) in order to protect their trade secrets. The reason being it allows their company to operate at a higher level and less risk. Things you should consider before signing…   Read more»

]]> 59dad69552d649c323ac73a386a4ccad https://medicaldevicecourses.com/activity/p/17395/ Wed, 15 May 2019 21:39:07 -0400 The difference between the verbal agreements and written agreements is that the written agreement is definitely easier to create, understand, and can be used as a proof to prove to someone or in court when there is a disagreement. While…   Read more»

]]> 36589c28a684abd9e816d4d9f17e6fdf https://medicaldevicecourses.com/activity/p/17393/ Wed, 15 May 2019 21:39:06 -0400 certainly, I agree with most of the participants in this post regarding Dr. Simon’s class. This is my first time taking the class with Dr. Simon. I am glad I took this course. I found this course helpful, therefore I…   Read more»

]]> 4d64f011f374160453e135f3d3c0ee8e https://medicaldevicecourses.com/activity/p/17296/ Wed, 15 May 2019 21:38:19 -0400 We had our first meeting on Friday after the initial meeting where we formed a team. We meet every Friday at 7 pm on Google Hangouts through a conference call to share our perspective status of the project with every…   Read more»

]]> 4c34703fbbaca8502be18b05ed834f32 https://medicaldevicecourses.com/activity/p/17294/ Wed, 15 May 2019 21:38:18 -0400 I believe in my opinion, the best way to form a project team would be with people who are more knowledgeable in their department role rather than working with people who you have a better relationship with. The reason being,…   Read more»

]]> 20d79abcf3f8168e7affcf72e8e2bc5d https://medicaldevicecourses.com/activity/p/17289/ Wed, 15 May 2019 21:38:16 -0400 I agree with many of the participants in here, matrix organization would be the best option to start my medical device company. There are many reasons, but one of the particular is that matrix organization is a combination of Project…   Read more»

]]> 2ce6c9e60ba4a6e269c2527c00e0c36f https://medicaldevicecourses.com/activity/p/17179/ Wed, 15 May 2019 21:37:18 -0400 There are several approaches used to manage risk in a project as mentioned by many in here. The fundamental steps for risk management are to establish the goals and context, identify risks, analyzing the identified risks, asses or evaluate the…   Read more»

]]> 1bc1826faee7a937e3ff182dd1394bd3 https://medicaldevicecourses.com/activity/p/17178/ Wed, 15 May 2019 21:37:18 -0400 All risk is valued by Failure Mode Effects and Criticality Analysis (FMECA). It is an approach to analyze risk. Certain factors that contribute to determining the risk values are how something can fail, the severity of the consequences, and the…   Read more»

]]> 5d919f7c7114cf1a664af57ab474e46b https://medicaldevicecourses.com/activity/p/17177/ Wed, 15 May 2019 21:37:17 -0400 As it was discussed in the slides by dr.simon, Risk management plan identifies and evaluates all the risk. One method that analyzes risk is by FMECA which stands for Failure Mode Effects and Criticality Analysis. Then documentation reviews take place…   Read more»

]]> 06b57f47aaf6e982eb3e6245894d1f74 https://medicaldevicecourses.com/activity/p/17106/ Wed, 15 May 2019 21:36:41 -0400 According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File. Each of these nine parts has their…   Read more»

]]> 2569c76e61a3fbae33a514f6c31fefa2 https://medicaldevicecourses.com/activity/p/17105/ Wed, 15 May 2019 21:36:41 -0400 Regarding the Gantt chart, I have yet to gain experience in the industry, but from my senior year capstone course, I do have experience in creating Gantt charts. A simple and basic essential you need to start the chart is…   Read more»

]]> 5f816ef69a3fe0932f21415aae3c5767 https://medicaldevicecourses.com/activity/p/17100/ Wed, 15 May 2019 21:36:38 -0400 The purpose of doing meeting minutes is to have everyone on the team and everything related to the project straighten out in order. It helps you to remember what was discussed in the meeting, where did it happen, who attend…   Read more»

]]> a3758c4ad60db7811ed70e896ef3dfc2 https://medicaldevicecourses.com/activity/p/16963/ Wed, 15 May 2019 21:35:30 -0400 Similar to mentioned already, validation is the process of making sure that the objectives meet the user needs and intended uses have met. certain methods that verify these details are through inspections, clinical trials, and design analysis. After the design…   Read more»

]]> 7bbbe3226bbfc2d2abd93a63d65a5c54 https://medicaldevicecourses.com/activity/p/16962/ Wed, 15 May 2019 21:35:30 -0400 Design Development Plan is certainly the crucial component in a project. DDP ensure traceability of design and development outputs and inputs to design. I think the quality management plan is more important than communication plan. The quality unit has the…   Read more»

]]> 3230f5a32543adc69a6effba79876940 https://medicaldevicecourses.com/activity/p/16961/ Wed, 15 May 2019 21:35:29 -0400 Indeed, it is important that medical system companies design and develop a medical device that is safe and efficacy for the consumers to use. FDA, IND and other regulatory organizations want to regulate the product and assure that the medical…   Read more»

]]> 0db5aff800bdfb88ef6bf0b88086bc42 https://medicaldevicecourses.com/activity/p/16900/ Wed, 15 May 2019 21:34:57 -0400 Blinding study was introduced to avoid bias in the evaluation of treatment effects. As you have mentioned, double blinding studies require blinding patient, who is unaware of which treatment is given and also blinding the investigator. Thus, it guarantee objective…   Read more»

]]> 6ae191f03b5b88a1294d69575aebb037 https://medicaldevicecourses.com/activity/p/16897/ Wed, 15 May 2019 21:34:55 -0400 Like you have mentioned, clinical tests takes place to evaluate the safety for human well being. Similarly, Pharmaceutical companies conduct clinical test to evaluate the safety and efficacy of their drugs. This tests are an important requirement to obtain regulatory…   Read more»

]]>