https://medicaldevicecourses.com/members/dkonara921/activity/ Activity feed for Dkonara921. Sat, 25 Apr 2026 02:14:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7680754bf7fd5c25d7c90c31ed4f26be https://medicaldevicecourses.com/activity/p/18351/ Wed, 15 May 2019 21:47:33 -0400 This class is quite helpful in providing insight as to what problems you will encounter in the future as a project manager or an engineer through the simulation reports. The simulation reports are complex problems that require careful thinking and…   Read more»

]]> f4b8041389605d900f166396fcc1d376 https://medicaldevicecourses.com/activity/p/18350/ Wed, 15 May 2019 21:47:32 -0400 I believe that leaving your place of employment simply because you don’t feel praised or recognized for your effort is understandable, but not a great reason. It’s not about trying to get recognition because the work you are doing is…   Read more»

]]> baa761e8a282ae5d6ffd8e33026c409e https://medicaldevicecourses.com/activity/p/18349/ Wed, 15 May 2019 21:47:32 -0400 Ideally, you would want to have any positive quality (e.g. work ethic, positive attitude, intelligence) as a project manager. Even though there are certain skills and qualities that may be less important than others or are just simply not relevant…   Read more»

]]> 31336a6bf20c488d5c5dd6b260a00300 https://medicaldevicecourses.com/activity/p/18300/ Wed, 15 May 2019 21:47:06 -0400 I would choose engineering because I feel that it is a great fit for me since I am the type of person who likes to design and solve problems in the most efficient way. Engineers try to design solutions that…   Read more»

]]> cf00106b1741d660b8daeacbdd466c51 https://medicaldevicecourses.com/activity/p/18299/ Wed, 15 May 2019 21:47:05 -0400 This class is helpful because it exposes students to the challenges and the difficulties that they will face in the workplace. All of the documents and logistics that have been covered in this course is exactly what will be expected…   Read more»

]]> 9118e37e7097f4d7e25efacf302972a1 https://medicaldevicecourses.com/activity/p/18298/ Wed, 15 May 2019 21:47:04 -0400 My biggest source of motivation would be the goals that I wish to achieve in life. I believe that the work you do every day has to lead to some ultimate achievement. Having life goals is something that allows me…   Read more»

]]> 6fe7cabbc9c5765d2f3cb15b2835fc68 https://medicaldevicecourses.com/activity/p/18214/ Wed, 15 May 2019 21:46:20 -0400 Project managers cannot simply integrate aspects of Six Sigma into their projects because the organization that they are working for may not be familiar with the methodology. If Six Sigma isn’t adopted as part of the organization’s culture, then it’s…   Read more»

]]> 0aec5f84b074ac83347a8da676ad5357 https://medicaldevicecourses.com/activity/p/18213/ Wed, 15 May 2019 21:46:20 -0400 The way that I think about this issue is that having a wider range of specification is good for many reasons. First of all, it gives a lot of leeway in terms of manufacturing the product and using the product….   Read more»

]]> 692efeb5d488266d766e614c63a2e242 https://medicaldevicecourses.com/activity/p/18212/ Wed, 15 May 2019 21:46:19 -0400 The easiest solution would be to consult the heads of your department which is where you received your former team member from and ask if you could get a replacement. This would seem like the best solution because obviously there…   Read more»

]]> 95937ca7c3993e1cc36e57870874e4a3 https://medicaldevicecourses.com/activity/p/18079/ Wed, 15 May 2019 21:45:13 -0400 Both planned value and actual costs matter during this phase because, unlike the other phases, the monitoring and controlling phase takes place for the duration of the entire project. It’s important for actual costs to be kept as minimal as…   Read more»

]]> e35eeeb31be2926e23f8612e81162963 https://medicaldevicecourses.com/activity/p/18069/ Wed, 15 May 2019 21:45:08 -0400 Schedule variance is defined as the difference between earned value and planned value. Some of the factors that can affect schedule variance are mostly contingencies such as: a worker can become ill or severely injured from the project, a vendor…   Read more»

]]> 0b248646ee477d5c63e4742bc24ca414 https://medicaldevicecourses.com/activity/p/18068/ Wed, 15 May 2019 21:45:08 -0400 Requiring a project team to report on the lessons learned is very important for many different reasons. Firstly, it’s essential for project teams to learn from their experiences so that members can perform better in future projects. Future projects will…   Read more»

]]> df9f4d8a379cad3f926361f77f71696d https://medicaldevicecourses.com/activity/p/17982/ Wed, 15 May 2019 21:44:22 -0400 Design validation is important because this is the step where you have to essentially prove that your project was successful. The fundamental purpose behind your project is to develop a product or service that will fulfill a need to a…   Read more»

]]> 32f0a499b3b8019827c83f1e3a849547 https://medicaldevicecourses.com/activity/p/17981/ Wed, 15 May 2019 21:44:21 -0400 I do agree with this statement because the aspects listed are crucial because of their significance. Information distribution is very important because project team members or at least those who should know something must know it. Lack of awareness of…   Read more»

]]> 88898394e310d2b79068127654089516 https://medicaldevicecourses.com/activity/p/17980/ Wed, 15 May 2019 21:44:21 -0400 The way I see it is that the design inputs that you write in must meet the needs of the customer because that is the ultimate purpose of this project. You are doing this project to produce something (e.g. a…   Read more»

]]> 4d82935e8b65df4bcd79cf7f22c7c3d3 https://medicaldevicecourses.com/activity/p/17873/ Wed, 15 May 2019 21:43:27 -0400 One particular challenge that project managers face is time management. As the leader of the entire team who is responsible for the entire project, time management can be something that is particularly difficult because there is a lot of work…   Read more»

]]> dc39332b215959424e8130166b985f1a https://medicaldevicecourses.com/activity/p/17864/ Wed, 15 May 2019 21:43:23 -0400 There are many factors that must be considered when evaluating a project change request. One such factor would be if the change would alter the business requirements. In other words, does the project try to produce results that the business…   Read more»

]]> ceaf761bcb78590b39262a6cdf8c615c https://medicaldevicecourses.com/activity/p/17860/ Wed, 15 May 2019 21:43:20 -0400 If the discussion doesn’t produce a solution, then it should be tried again and again until it does because the project team is responsible for everything about the project. It’s important for them to have efficient communication with each other….   Read more»

]]> 0b73e945ca184f32c708a7b1fa608a3c https://medicaldevicecourses.com/activity/p/17859/ Wed, 15 May 2019 21:43:20 -0400 The Risk/Benefit Ratio is a way of comparing the risks of an action to the benefits that will come if that action is taken. If the benefits are relatively high compared to the risks, then it’s mostly worth taking the…   Read more»

]]> 8e2ae63a8c6dd2c7c538c0ed44f92f89 https://medicaldevicecourses.com/activity/p/17858/ Wed, 15 May 2019 21:43:19 -0400 One way to think about solving this problem is to brainstorm any potential risks that may arise while doing the actual project. I think that getting input from people who’ve had experience in doing the tasks similar to the ones…   Read more»

]]> 7c018bf91ee91437017c230f05f760d1 https://medicaldevicecourses.com/activity/p/17857/ Wed, 15 May 2019 21:43:19 -0400 In my opinion, I think that it really depends on the milestone that you missed and what the results would’ve been had you not missed the milestone. Missing a milestone could make the project run easier because you are focusing…   Read more»

]]> 43c1adc9b78ef622d91570f193fcf38e https://medicaldevicecourses.com/activity/p/17750/ Wed, 15 May 2019 21:42:19 -0400 Agreeing on the project goals is important because the team needs to understand the purpose behind the project and what is expected to come out of their efforts. If every team members understands what the project goals are, they will…   Read more»

]]> 2247ca81877a85341d7f3c7ea438a6bb https://medicaldevicecourses.com/activity/p/17746/ Wed, 15 May 2019 21:42:17 -0400 Another important measure that is important when considering the medical device is how frequently the device will be used by the user or how long the device will last. For instance, if the device is an electronic device, important questions…   Read more»

]]> 50be22e5e2882e6062a35a90eb3a4e4b https://medicaldevicecourses.com/activity/p/17745/ Wed, 15 May 2019 21:42:17 -0400 Input from any different department (e.g. Marketing, Regulatory, Engineering) can only help in improving the efficiency of the device. There many be someone who doesn’t offer a feasible specification but it can always be rejected. Asking for input from any…   Read more»

]]> 34a379ee9f9ff46439ee359fff742f0e https://medicaldevicecourses.com/activity/p/17679/ Wed, 15 May 2019 21:41:42 -0400 In case of an emergency, an unapproved medical device could be used if there is some enough that is has created positive results and has been tested in trials. As someone previously stated, there are about 4,000 patients each year…   Read more»

]]> 7884e5e5dbdbb6d5cc291b05b86ffeba https://medicaldevicecourses.com/activity/p/17676/ Wed, 15 May 2019 21:41:40 -0400 Picking a project team is probably the most crucial task and hardest challenge for a project leader. There is no absolute right/wrong answer when picking a team as individuals have different strengths and weaknesses which can either strengthen or weaken…   Read more»

]]> 908b06403b3c1ae3745a2d3da84dc20f https://medicaldevicecourses.com/activity/p/17675/ Wed, 15 May 2019 21:41:39 -0400 I do believe that the medical device community is progressing towards a global system of regulating medical devices. I think that as more countries get more industrialized and gain more technology, countries will “go with the flow” and adopt regulatory…   Read more»

]]> 0163401a0b8358245b4e3578cdd70d4d https://medicaldevicecourses.com/activity/p/17596/ Wed, 15 May 2019 21:40:55 -0400 The quality plan is needed for many different reasons. The quality plan document verifies the internal and external standards and procedures. Besides that, the document also provides some insight as the business’ quality management system because it requires one to…   Read more»

]]> 16231a1d711e2d62d371a4c104b72fa9 https://medicaldevicecourses.com/activity/p/17595/ Wed, 15 May 2019 21:40:55 -0400 Some advantages of the Functional Organization is that the departments operate somewhat independently of each other so coordination between members of a department is much easier because they can only rely on each other during a project. All decisions are…   Read more»

]]> f5ef25dc0c68ad5af960ec28bfd5e271 https://medicaldevicecourses.com/activity/p/17594/ Wed, 15 May 2019 21:40:54 -0400 The way that I think about a project proposal document is that it is a formal way of persuading the leaders of your company, such as CEOs, managers, and stakeholders, that your project is worth investing in and that it’s…   Read more»

]]> de9fa801ae2e6c164ff77e685f5763a6 https://medicaldevicecourses.com/activity/p/17498/ Wed, 15 May 2019 21:40:02 -0400 I think that this would depend on the information on the labels of the products. If there were important safety information or details regarding use, then the product should be recalled because customers will complain about the product if it…   Read more»

]]> 23660a1c25bca32e10447a750e44da5d https://medicaldevicecourses.com/activity/p/17497/ Wed, 15 May 2019 21:40:01 -0400 I think that the company should fund the project if it has sufficient funds. If the firm doesn’t have enough to fund two or more proposed projects, then the one that offers the least risk or requires less money should…   Read more»

]]> b5d370759cf2268a79f3b43bad74c58d https://medicaldevicecourses.com/activity/p/17496/ Wed, 15 May 2019 21:40:01 -0400 I believe that it’s extremely important for an employee to be able to pick a good group of people for a project team because doing a project is a team effort. Not only does it matter that each individual member…   Read more»

]]> d76af5c11437bdd2f69398c2c19d1041 https://medicaldevicecourses.com/activity/p/17449/ Wed, 15 May 2019 21:39:37 -0400 The reason why formulating the project idea is the hardest part is because it is the foundation for the entire project. The project that you run is meant to turn your ideas into reality. Without a solid idea, you cannot…   Read more»

]]> 970a6f9fd0fbc452802f02e5f9aa44dc https://medicaldevicecourses.com/activity/p/17448/ Wed, 15 May 2019 21:39:36 -0400 I think that the BME curriculum does not reflect the author’s perspective because there are virtually no courses that teach interpersonal skills. However, I think that the investment is still justified because it’s important for future engineers to know the…   Read more»

]]> fb48070df19343e94f4f8f7d6365a370 https://medicaldevicecourses.com/activity/p/17447/ Wed, 15 May 2019 21:39:36 -0400 I actually agree with the statement that interpersonal skills should be valued more than technical skills or book knowledge. My reasoning is that in my experience, people who are skilled at dealing with people and know how to work with…   Read more»

]]> bc8069ed322103a924192137e89bf36b https://medicaldevicecourses.com/activity/p/17340/ Wed, 15 May 2019 21:38:40 -0400 Verbal means any communication that involves words, which means that oral and written agreements are both verbal agreements. I think you meant “what is the difference between Oral and Written Agreements?” An oral agreement is harder to prove because it…   Read more»

]]> 816a763ffd282dca6ea38008fd2136d6 https://medicaldevicecourses.com/activity/p/17337/ Wed, 15 May 2019 21:38:39 -0400 In my opinion, I understand why this may seem pretty awkward and I don’t think it’s a problem at all to pay for the physician’s wife but I do see the reasoning behind it. The physician could bring more colleagues…   Read more»

]]> 0fe636c1386feac45e7712a7105a9857 https://medicaldevicecourses.com/activity/p/17335/ Wed, 15 May 2019 21:38:38 -0400 Overall, I thought that the content of this course was excellent. One thing that I particularly found helpful were the lecture presentation slides. The content in the slides were pretty clear and concise. This is my first online course in…   Read more»

]]> 090a544875df94cc81c986db1c1e8a50 https://medicaldevicecourses.com/activity/p/17305/ Wed, 15 May 2019 21:38:24 -0400 For my team, I completed the DID and my partner completed the RA document. We haven’t had our first meeting yet due to conflicts but so far the project is going quite smoothly. One of the challenging things about working…   Read more»

]]> 14547005324ed056b7440af21fec3945 https://medicaldevicecourses.com/activity/p/17303/ Wed, 15 May 2019 21:38:23 -0400 Organizational culture and structure can influence a project in many different ways. It will definitely impact what resources the business is willing to allocate for your project and how quickly and efficiently it can be done. Sometimes, the problem with…   Read more»

]]> 941716f2ab7e93d434c5c09e2fdc2eeb https://medicaldevicecourses.com/activity/p/17301/ Wed, 15 May 2019 21:38:22 -0400 For selecting members for my project team, I would look at what individuals are very enthusiastic or very interested to join in on the project. Having people who are curious and committed is crucial because if they lack interest of…   Read more»

]]> cba0e67c7dc8e1567b53179f03dbc7fc https://medicaldevicecourses.com/activity/p/17138/ Wed, 15 May 2019 21:36:58 -0400 In my opinion, I would say that avoidance is the best option for high severity of risk because this level of risk is something that can have detrimental effects on a business. A s Benjamin Franklin once stated, ” An…   Read more»

]]> 1ed480433a271e893c31375c9dd91f5f https://medicaldevicecourses.com/activity/p/17137/ Wed, 15 May 2019 21:36:58 -0400 The way that I interpret this regulation is that companies have to prove that their manufacturing processes are performing at the most optimal level possible. It’s impossible to have a 100% efficient system, many of the things that happen in…   Read more»

]]> 98e45c45d17223392a3f42622747bb1a https://medicaldevicecourses.com/activity/p/17136/ Wed, 15 May 2019 21:36:57 -0400 I think that using these regulations costs money simply because it’s a service that businesses and companies can use to show that they are complying with regulations and not trying to take the easy way out when it comes to…   Read more»

]]> 143a0a808f985df2d8498fb7500882d3 https://medicaldevicecourses.com/activity/p/17103/ Wed, 15 May 2019 21:36:40 -0400 The design input essentially details what is expected of your finished product. Sources of design input can be taken from market research to see what consumers want and how to make improvements on your product that they were initially not…   Read more»

]]> 7d7b907e209c5851095ef84ec65f3de0 https://medicaldevicecourses.com/activity/p/17101/ Wed, 15 May 2019 21:36:39 -0400 In my opinion, the team member list and management part is the most important aspect of the DDP because this will lead to many negative consequences. It’s very important for everybody involved to be aware of not only his/her responsibilities…   Read more»

]]> 6bf70f88d89c2fd7b2ddccc71a0d9d76 https://medicaldevicecourses.com/activity/p/17098/ Wed, 15 May 2019 21:36:37 -0400 The purpose behind pre-clinical and clinical trials is to determine how a product or service performs on a group of test subjects. Without clinical trials, there will be no way to determine the efficacy of the product or if the…   Read more»

]]> d6b57998aaa33229e7850931729d63b2 https://medicaldevicecourses.com/activity/p/17002/ Wed, 15 May 2019 21:35:50 -0400 Both documents are necessary because they are used to describe the product in the two major ways you can describe anything: qualitatively and quantitatively. The DID is the document in which the writer can briefly describe the essential features of…   Read more»

]]> 52b63b903837f2c9c588a01e4d6ee322 https://medicaldevicecourses.com/activity/p/17001/ Wed, 15 May 2019 21:35:49 -0400 A good way to think about Design Controls is that it is a systematic approach that is used for one main purpose: to ensure that a developed complies with the imposed regulations. It describes the entire process in which a…   Read more»

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