https://medicaldevicecourses.com/members/puneet/activity/ Activity feed for puneet. Sat, 25 Apr 2026 02:56:45 -0400 https://buddypress.org/?v= en-US 30 hourly 2 168cd18d91bade58c2f40899013aa6c3 https://medicaldevicecourses.com/activity/p/16018/ Wed, 15 May 2019 19:16:12 -0400 I think that the most useful part of this class was that it offered a more practical course as compared to the majority of courses that are strictly academic. I think that it is important to have practical courses because…   Read more»

]]> b9c00b4d58f825a3c5735fc803137902 https://medicaldevicecourses.com/activity/p/16016/ Wed, 15 May 2019 19:16:11 -0400 Depending on the project, I think that it is possible to focus on more than one priority. It would be important to rank each priority of the project – low, medium, high so that the highest priority priorities are given…   Read more»

]]> 7732c3b86aed42e8400bc934b3018aaf https://medicaldevicecourses.com/activity/p/16015/ Wed, 15 May 2019 19:16:10 -0400 I think that this course was very useful and provided a lot of useful information for anyone who plans to work in the medical device industry in the future or even people who are currently working in industry especially as…   Read more»

]]> f978d0196fdee2bede48d8df34be3bc1 https://medicaldevicecourses.com/activity/p/15917/ Wed, 15 May 2019 19:15:14 -0400 Retaining key employees is an important consideration for a company to be successful. Retaining these key employees also retains all of the knowledge that person has from working on past company projects which is a useful asset that a new…   Read more»

]]> 5ce03a1e577eecb7b3527ccbfa5869ff https://medicaldevicecourses.com/activity/p/15915/ Wed, 15 May 2019 19:15:13 -0400 I stay motivated by setting and reaching goals. Short term and long term goals are a good way to stay motivated for the long haul. Setting a short term goal and achieving it requires someone to stay on track and…   Read more»

]]> bd74f3ef8db094f8cc2a0a60c1d4891f https://medicaldevicecourses.com/activity/p/15914/ Wed, 15 May 2019 19:15:13 -0400 I think that there are many reasons someone may leave a certain job including finding a better opportunity elsewhere, being frustrated with their current work assignments, or issues with people in the organization. Someone may leave a job because the…   Read more»

]]> e6f2098f776791b3537e90509ed79c05 https://medicaldevicecourses.com/activity/p/15779/ Wed, 15 May 2019 19:13:48 -0400 Communication management is very important in the success of a project and an organization, making the communications management plan a very important document. The communications management plan sets up important things such as how often communication will occur. This is…   Read more»

]]> d8f46721693418270bbd72e736cc258a https://medicaldevicecourses.com/activity/p/15778/ Wed, 15 May 2019 19:13:48 -0400 I think that reducing turnover and retaining top employees are important considerations for an organization especially in the medical device industry when it comes to human resource management. Retaining key employees over the long term can be very beneficial because…   Read more»

]]> e21dad8a265855c8451835b7a07fcc77 https://medicaldevicecourses.com/activity/p/15775/ Wed, 15 May 2019 19:13:46 -0400 Accurately breaking down the work breakdown structure is a very important aspect for a successful project, because it breaks down and organizes each task of the project. If the WBS is not well constructed it can cause project delays, missed…   Read more»

]]> 6d64ed734e8944af0d8aad02d26d8dba https://medicaldevicecourses.com/activity/p/15644/ Wed, 15 May 2019 19:12:26 -0400 All five of these factors are critical for the project to be successful, but I think that the most important out of those is effective communication. Effective communication between all parties working on the project is required for all of…   Read more»

]]> ad1442878c4239783f86ede6f5087313 https://medicaldevicecourses.com/activity/p/15643/ Wed, 15 May 2019 19:12:26 -0400 The different kinds of changes made during the monitoring and controlling phase include non essential design changes, design change numbers, and engineering change order. Non essential design changes involve a change to the design control document while the product is…   Read more»

]]> 5c58de4f758fb3a80bb4201141f6d466 https://medicaldevicecourses.com/activity/p/15641/ Wed, 15 May 2019 19:12:24 -0400 During the closing phase of the monitoring and controlling phase some of the important processes include: closing out contracts, paying all people who need to be paid, giving final performance reviews, keep track of what you learned during the project,…   Read more»

]]> a89628597ec839ae24a617a84777dd31 https://medicaldevicecourses.com/activity/p/15549/ Wed, 15 May 2019 19:07:32 -0400 Metrics offer a way to quantitatively describe the project as it moves along. Metrics can be used to evaluate the success of the project and also compare the project to the original estimates made for the project. Management can use…   Read more»

]]> 9f3a5789c77954c680b46dec6ffc9a1f https://medicaldevicecourses.com/activity/p/15547/ Wed, 15 May 2019 19:07:31 -0400 The schedule variance could be affected by many factors such as how accurate the project manager was when first establishing the schedule. It is possible that the project manager overestimates the amount of time different aspects of the project will…   Read more»

]]> e136d9de6e54c5572597577145b11da2 https://medicaldevicecourses.com/activity/p/15546/ Wed, 15 May 2019 19:07:30 -0400 I don’t think there are many cases where it would be acceptable to increase project risk to shorten the time duration of the project. Depending on the project adding more risk to an already moderate to high risk device could…   Read more»

]]> 231ff2dc208c4cdc37a145e0fca1a925 https://medicaldevicecourses.com/activity/p/15424/ Wed, 15 May 2019 19:06:09 -0400 One way to prevent scope creep is to have regularly scheduled check-ins with all team members to make sure that they are all working on things that are in-scope for the project. This could be a quick web meeting, over…   Read more»

]]> 5955b7a928d0e882b279f4e6af290e34 https://medicaldevicecourses.com/activity/p/15422/ Wed, 15 May 2019 19:06:08 -0400 I think that the criticality of the part being outsourced would have a great impact on the degree of background work that is done on a potential vendor. For example a low criticality part may not require as much research…   Read more»

]]> 4725cd5b84d5e1f74aea6e3be9dcf25e https://medicaldevicecourses.com/activity/p/15421/ Wed, 15 May 2019 19:06:08 -0400 The best way to deal with a project team member like Patty, is to get her to understand why things need to be changed and communicate to her the importance. In this simulation, we had the choice of scheduling a…   Read more»

]]> 0611f40ce3a5744ef3cfd987f732a89d https://medicaldevicecourses.com/activity/p/15337/ Wed, 15 May 2019 19:05:22 -0400 When working on my senior design project during my undergrad there were several times where we missed a milestone. The way we approached this was to continue working on the milestone as we progressed with other tasks on our schedule….   Read more»

]]> 72c28fe0b0b04c8f795c7538f1e40c18 https://medicaldevicecourses.com/activity/p/15335/ Wed, 15 May 2019 19:05:21 -0400 I think the best way to meet deadlines in this scenario is to give the planning phase of the project proper consideration and devoting as much time to research as possible. The more research that can be done, the more…   Read more»

]]> 9b705ea62ec846db1f07e6d0b30b4437 https://medicaldevicecourses.com/activity/p/15334/ Wed, 15 May 2019 19:05:20 -0400 I think that the best way to deal with an unresponsive team member is to schedule a meeting with them either in person or over the phone. In the meeting I would discuss their unresponsiveness with them and hear from…   Read more»

]]> d332e24176a8ab789e7b530bf605a6c4 https://medicaldevicecourses.com/activity/p/15235/ Wed, 15 May 2019 19:04:18 -0400 I think that it is important that the project manager remains ethical while facing the pressure of a timeline with rapidly approaching deadlines. Any unethical behavior from a project manager could add a ton of risk to a device that…   Read more»

]]> 50ea4f7040d11cfb8749dadcf24a6d1a https://medicaldevicecourses.com/activity/p/15233/ Wed, 15 May 2019 19:04:17 -0400 I think that risk management successfully begins in the planning phase of the project. The more risks and roadblocks that can be identified before the project begins the better equipped the project team will be to handle risks as they…   Read more»

]]> 5dc3cc6edd4245a4606782f932b604ce https://medicaldevicecourses.com/activity/p/15232/ Wed, 15 May 2019 19:04:16 -0400 I think that the planing phase is one of the most important phases of the lifecycle of the project. In the planning phase, the entire remaining lifecycle of the project is mapped out. It is important that during the planning…   Read more»

]]> d364e09922a61d555b75079bf3180fdf https://medicaldevicecourses.com/activity/p/15089/ Wed, 15 May 2019 19:02:57 -0400 An engineering change order is an important part of a project and it begins when someone on the project team identifies an issue or problem that may require a change to be made. After an issue has been identified and…   Read more»

]]> 776fcfc5c3ccb98eceb20d21096b80cf https://medicaldevicecourses.com/activity/p/15087/ Wed, 15 May 2019 19:02:56 -0400 I think that the phrase “everything is about risk” refers to the fact that any decision that is made on a project, that the first consideration will be the risk involved. From beginning to end all decision are made with…   Read more»

]]> 369c515fbfe6d32c7da9823b9366fa8f https://medicaldevicecourses.com/activity/p/15086/ Wed, 15 May 2019 19:02:55 -0400 I think that risk/benefit ratio is something that comes up throughout the entire lifecycle of the project. Risk is a major concern regarding medical devices because an issue could lead to serious injury or death if the device malfunctions. The…   Read more»

]]> a03688f60d8691b6dd52f9d2005a2d16 https://medicaldevicecourses.com/activity/p/15006/ Wed, 15 May 2019 19:02:07 -0400 I don’t think that an issue such as labels peeling off of the bottle when submerged underwater, would be enough to warrant a recall but the company would still likely respond if many customers were having complaints. Having a label…   Read more»

]]> 530d32f2d1ee4ac762ebcc8f6b259d31 https://medicaldevicecourses.com/activity/p/14980/ Wed, 15 May 2019 19:01:54 -0400 Medical devices classifications are broken down into class I, class II, and class III devices. How a device is classified depends on how much of a risk the device presents to the user and how novel the device is. It…   Read more»

]]> 8355c94831dcb6ffeb2787b0a3fe2383 https://medicaldevicecourses.com/activity/p/14978/ Wed, 15 May 2019 19:01:53 -0400 I think that the company should definitely explore ways that they could take on that project if they really believe in its potential even if they don’t have the funding. For a small new company there are many different avenues…   Read more»

]]> b9397b3ba906570ac6173a38a576bd8b https://medicaldevicecourses.com/activity/p/14861/ Wed, 15 May 2019 19:00:52 -0400 I think that using a different material can definitely cause a change in the product classification of a product. The overall impact of the material being used depends on what the material being used is and whether or not it…   Read more»

]]> 0587a1ff8e896e562b6efe28eb035c30 https://medicaldevicecourses.com/activity/p/14859/ Wed, 15 May 2019 19:00:50 -0400 I don’t think there are any risks involved in performing validation and verification, rather performing validation and verification reduces the overall risk of the project by ensuring quality and that the product meets all requirements and specification and fulfills its…   Read more»

]]> 3bfedbe899dcf578d2ebe906a70a9395 https://medicaldevicecourses.com/activity/p/14855/ Wed, 15 May 2019 19:00:48 -0400 I think that the quality plan is important because the quality plan defines how quality can be achieved in a project. Quality plans determine a plan for meeting relevant quality standards and maintaining quality through the project with quality events….   Read more»

]]> b587b8d25106cebf009182a88b501a3d https://medicaldevicecourses.com/activity/p/14703/ Wed, 15 May 2019 18:59:20 -0400 In the case of an implant coated with antibiotics, I would guess that the FDA would designate the product as a device because its primary mode of action would be as an implant, not as a antibiotic. The reason being…   Read more»

]]> 19d4690a5952c0a72a509abf9a97f4cb https://medicaldevicecourses.com/activity/p/14701/ Wed, 15 May 2019 18:59:19 -0400 I think that Fitbit and other fitness wearables don’t fall under devices to be regulated by the FDA. The reason being that they aren’t truly medical devices as they don’t make any medical claims. As a general wellness product Fitbit…   Read more»

]]> 18eafe10782222494fe8eb487ca3a4b9 https://medicaldevicecourses.com/activity/p/14699/ Wed, 15 May 2019 18:59:18 -0400 I agree that it would be unethical for a company to embellish their product to try to get it classified as a type II device rather than a type III device because of the large risk associated with class III…   Read more»

]]> 6a875d947e5435924dcdcf1f06ffc60f https://medicaldevicecourses.com/activity/p/14680/ Wed, 15 May 2019 18:59:08 -0400 I think that a balance of the two skills is needed and agree with 85:15 ratio of interpersonal skills to technical skills. I think its important for biomedical engineering students to focus on technical skill rather than interpersonal skills for…   Read more»

]]> f5001e022ce6de1c8a32213205e9e24f https://medicaldevicecourses.com/activity/p/14677/ Wed, 15 May 2019 18:59:06 -0400 I think that the primary mode of action of the digital Abilify pill makes it a drug, rather than a device. This digital pill is more of a pill that comes with a sensor than it is a sensor that…   Read more»

]]> 81525bf6bd750fe5e36ad9a7a0dfcdd7 https://medicaldevicecourses.com/activity/p/14676/ Wed, 15 May 2019 18:59:06 -0400 I think that the priority of a project plays a huge role on the resources that are devoted to the project. The priority of the project will likely depend on how much the company can benefit from the success of…   Read more»

]]> 5b7d8f18202120c4229a1545b5edc6bb https://medicaldevicecourses.com/activity/p/14470/ Wed, 15 May 2019 18:57:14 -0400 When it comes to severance agreements a company would want your signature agreement on the separation, even in the case of at will contracts to limit the legal issues you can take. I believe most severance packages a company would…   Read more»

]]> 5d33ae42724474e6ad4bdc4453194982 https://medicaldevicecourses.com/activity/p/14469/ Wed, 15 May 2019 18:57:14 -0400 I believe that written contracts are favorable to verbal contracts because of how much easier it is to enforce and defend that contract. With everything written out, anytime a potential issues regarding the contract arises it is far easier to…   Read more»

]]> f2789062e3df58d974a784e2b07a2203 https://medicaldevicecourses.com/activity/p/14465/ Wed, 15 May 2019 18:57:12 -0400 These restrictions do seem very harsh, but I believe that they are necessary to maintain an ethical business environment. In the case of not being able to pay for dinner for the physician’s wife I think it is important to…   Read more»

]]> 1ea399b33068c88e5efdb5250d77a535 https://medicaldevicecourses.com/activity/p/14303/ Wed, 15 May 2019 18:54:56 -0400 I think completion between teams can often be beneficial as long as that completion is healthy and friendly. The key I believe in staying away from negative completion is strong communication and collaboration between departments. A closer knit work environment…   Read more»

]]> 060a39631f316fe7d95ba614294ed9db https://medicaldevicecourses.com/activity/p/14301/ Wed, 15 May 2019 18:54:55 -0400 My current position is in a functional organization where each department team has a functional manager to whom other team members report to. I think this style work well for us as each department needs to concentrate their focus on…   Read more»

]]> 9230d40496daa1a782d86b049ad00a85 https://medicaldevicecourses.com/activity/p/14300/ Wed, 15 May 2019 18:54:55 -0400 I think I would be more suited for choosing upper management, but I also think I would be able to work in middle management as well. I also agree with the assertion that upper managers should spend time in middle…   Read more»

]]> ebae121fcf5e1bbc83b8f7a537db4ce6 https://medicaldevicecourses.com/activity/p/14192/ Wed, 15 May 2019 18:52:55 -0400 Risk-benefit analysis is an important consideration for a product. Part of the risk management framework is to decide what risks that you are willing to take with a product. It is important to identify what kind of risks that you…   Read more»

]]> 15a2ce2d36369ddef5af490e88211e6d https://medicaldevicecourses.com/activity/p/14190/ Wed, 15 May 2019 18:52:54 -0400 Risk factors depend on variables such as the severity of the risk, likelihood a particular risk occurs and the types of risks that they are willing to take. The severity of a risk can be severe, critical, significant, or minor…   Read more»

]]> 23d813aafc144de6981275f94952faa9 https://medicaldevicecourses.com/activity/p/14174/ Wed, 15 May 2019 18:52:44 -0400 I agree that the phrase “as far as possible” is broad and difficult to quantify. Because there is no way of knowing how many risks that may exist but haven’t been identified. Because of this it isn’t possible to reduce…   Read more»

]]> bb4e207c341a88ee2f8cad13ae26e7c3 https://medicaldevicecourses.com/activity/p/14045/ Wed, 15 May 2019 18:51:23 -0400 All parts are very critical so it is difficult to say which is most important but I’d like to highlight the team member list/responsibilities section. For the project to move slowly assigning the right team members to the right role…   Read more»

]]> 301834c4a72c9a4e086a0a29d49c58d2 https://medicaldevicecourses.com/activity/p/14043/ Wed, 15 May 2019 18:51:22 -0400 The only medical devices used outside the body that likely wouldn’t need clinical trials are probably low risk devices where there are already substantially equivalent devices on the market such as gauze, stretchers, walkers, surgical masks, stethoscope, or a gait…   Read more»

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