https://medicaldevicecourses.com/members/aja38/activity/ Activity feed for aja38. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8cf574f51f0fb534d44d9af0eae31822 https://medicaldevicecourses.com/activity/p/18353/ Wed, 15 May 2019 21:47:34 -0400 To me overtime can be both a motivator or a demotivator. The reason being is that maybe people work overtime shifts for earning a few more bucks for something they want or need. Another reason I see that people work…   Read more»

]]> c00d7a26c0dc779ac53cf10a44061932 https://medicaldevicecourses.com/activity/p/18348/ Wed, 15 May 2019 21:47:31 -0400 As other stated I do agree but there are many reason why people leave. Limited recognition and praise is one because people that work for a company for a long time and they see no future progression, they can decide…   Read more»

]]> 128be2c77c0940507d9e4d0781161836 https://medicaldevicecourses.com/activity/p/18346/ Wed, 15 May 2019 21:47:30 -0400 I think motivation is important for every industry/ work environment. Some ways that project managers can promote motivation is have open communication, recognizing employee hard work, and make work challenging to interest employees. The level motivation does effect because it…   Read more»

]]> cf7ed0869cea942e7d8d907a8e0de1e7 https://medicaldevicecourses.com/activity/p/18289/ Wed, 15 May 2019 21:47:00 -0400 I really would like working for an engineering role because I would like being the one that preform test engineering, fabricating, etc. but as of right now I see myself first starting off as a management role because they would…   Read more»

]]> a57552f7c8c98282e621fff629047c97 https://medicaldevicecourses.com/activity/p/18287/ Wed, 15 May 2019 21:46:59 -0400 I agree with everyone, tunnel vision isn’t something that people should have because it will be limiting your option, it will prevent one to be creative. There are many solutions out there in the world but tunnel vision will veer…   Read more»

]]> 009704b18306bea26160350c9bb0de9b https://medicaldevicecourses.com/activity/p/18286/ Wed, 15 May 2019 21:46:58 -0400 This course was very helpful because it helped with real life simulation experience. It slowly progressed harder as we tackled each simulation. The lecture helped giving me more background on management process of project and that project managers are responsible…   Read more»

]]> 0e90b3afa66997be864fb65964bde33b https://medicaldevicecourses.com/activity/p/18206/ Wed, 15 May 2019 21:46:16 -0400 There should always be a backup plan if this situation every happens and I don’t believe that someone can leave without month or two week notice. But even though this happens I would have contact info from former worker and…   Read more»

]]> 554612328a738980e1aaf23c2367a5a5 https://medicaldevicecourses.com/activity/p/18202/ Wed, 15 May 2019 21:46:14 -0400 Both quality assurance and quality control ensure the safety. Quality Assurance focus on the planning process and how closely the project is following to prevent any risk from arising . Quality Assurance verifies if everything is as plan. Quality control…   Read more»

]]> cf305be85db33b53cfd9d0dd61a8713d https://medicaldevicecourses.com/activity/p/18195/ Wed, 15 May 2019 21:46:11 -0400 I believe that communication has to be implemented to everyone but the project manager should enforce and create a safe environment for everyone to be comfortable to communicate. However, if one of the members from the project group is still…   Read more»

]]> c361ce762147730ed53ffb2ab787a221 https://medicaldevicecourses.com/activity/p/18135/ Wed, 15 May 2019 21:45:41 -0400 As many stated, weather, missing member due to sickness, vacation, or personal problems, resource problems, and budget problems can cause affect schedule variance. All these issues can cause work delay. These can be unpredictable but the risk management should help…   Read more»

]]> c64050f0d2801b86f9f4f2a3bfc9f866 https://medicaldevicecourses.com/activity/p/18133/ Wed, 15 May 2019 21:45:40 -0400 Both plans are good but I believe that when SV is neagative and cost variance is positive would be a better plan because you would be under budget. The work being done is slacking but it could be fixed if…   Read more»

]]> 761939dd52e2eec4e4b7dedba1b17b10 https://medicaldevicecourses.com/activity/p/18131/ Wed, 15 May 2019 21:45:39 -0400 If an employee is absent due to vacation or personal problem then the project will be delayed if no planning was made prior to the employee leave. The project manager should get a head notice before the employee has to…   Read more»

]]> 8e152b8322a59fa939835cfcce9665e7 https://medicaldevicecourses.com/activity/p/18058/ Wed, 15 May 2019 21:45:03 -0400 Scheduled variance equals earned value minus planned value. If the planned value increase making the solution negative then the project is behind in schedule. There is anything that can delay the project whether being testing problems, weather problems, employ problems,…   Read more»

]]> 4eeda4fa2450d850be61a8b7391f6fa4 https://medicaldevicecourses.com/activity/p/18057/ Wed, 15 May 2019 21:45:02 -0400 Time is money and in order the project to run, money is involve. Monitoring and controlling phase will take time and there is a planned dates where a predicted value is targeted and reached as plan. After everything is completed…   Read more»

]]> d606be9611dd0a6e8dc10a0a1169a071 https://medicaldevicecourses.com/activity/p/18056/ Wed, 15 May 2019 21:45:02 -0400 There is not just one important technique, there are varieties. Project plan, Performance report, and change request are the main components in monitoring and controlling the project. The project already has a plan from the start and if something is…   Read more»

]]> e8f4b017f4d6231666f79a4370f4cb68 https://medicaldevicecourses.com/activity/p/17993/ Wed, 15 May 2019 21:44:28 -0400 I would hold a meeting regarding the situation with all vendors and project departments involve and devise a plan to resolve as quick as it can. The first plan would be testing each part of the product in order to…   Read more»

]]> 89f98067c208899372d2b8a66a971315 https://medicaldevicecourses.com/activity/p/17990/ Wed, 15 May 2019 21:44:26 -0400 Design validation is important in design management. The reason being is that it helps make sure that the product passes all test protocol. The test that that are preform during the validation process, examine shelf life, health protocol, efficiency, etc….   Read more»

]]> f03ebf34b4caaf93d22e60a7b57795f5 https://medicaldevicecourses.com/activity/p/17987/ Wed, 15 May 2019 21:44:25 -0400 What I would do is hold a meeting between research group and other departments. Here we will discuss, what methods we can use and make a new time schedule so we can be able to fix the problem on time…   Read more»

]]> 9adb35103b44921afa3fc50d54f136f0 https://medicaldevicecourses.com/activity/p/17943/ Wed, 15 May 2019 21:44:03 -0400 I agree that delays are unavoidable. There will always be an obstacle in the way whether being a product problem. But if there is a scheduled plan on how to go about the project then the risk of delays will…   Read more»

]]> 02161c5750b5671f772c7e2207bec1cf https://medicaldevicecourses.com/activity/p/17941/ Wed, 15 May 2019 21:44:02 -0400 Logging works is very important because it helps keeps track on what is happening and who was responsible for what has been done. I remember in my capstone class, when my group and I were creating an electrospun mat we…   Read more»

]]> 595702cb4c96a63592b4906b4c541f0b https://medicaldevicecourses.com/activity/p/17936/ Wed, 15 May 2019 21:43:59 -0400 Planning is one of the important phase like many said. It is basically the game plan if the team does not have a plan, there will chaos because there is no order which they can follow. The team will be…   Read more»

]]> a9f392e49ebe494637603614278da057 https://medicaldevicecourses.com/activity/p/17871/ Wed, 15 May 2019 21:43:26 -0400 I agree with other stating that it the scope should be clarified in the beginning of the project but also throughout the project because as stated by ks629 someone might want to sell the product oversea. The company needs enough…   Read more»

]]> 90e0d6ad515201046f6f88a12c6fd7c4 https://medicaldevicecourses.com/activity/p/17861/ Wed, 15 May 2019 21:43:21 -0400 I agree with everyone that says that the project manager should discuss with each member throughout the duration of the project. In the beginning, Project managers should already have schedules of all members. If there is an emergency, I would…   Read more»

]]> 85f817aebc2d4838e7a5f3c9ef623d94 https://medicaldevicecourses.com/activity/p/17855/ Wed, 15 May 2019 21:43:17 -0400 Some problems I feel that project manager can face is the team they choose, time is another problem and communication which everyone mentioned. The team can be a problem because there could be team members that aren’t putting anything on…   Read more»

]]> bee6b806f76b7caa0e5c21a4af879338 https://medicaldevicecourses.com/activity/p/17792/ Wed, 15 May 2019 21:42:40 -0400 I think both time and risk are important, but if I had to choose losing a project or getting law suits from harming the public, I would choose increasing testing time because safety is number 1. I could not be…   Read more»

]]> 4c5db83fcf78353b189141af30df5128 https://medicaldevicecourses.com/activity/p/17788/ Wed, 15 May 2019 21:42:38 -0400 As everyone stated this is very bad because it is a critical part of the device’s function. The first thing I would do is check the deadline because I need to see how much time I have left to see…   Read more»

]]> 13b831587f8b2e9fa1db977e44eed4f7 https://medicaldevicecourses.com/activity/p/17786/ Wed, 15 May 2019 21:42:38 -0400 I think the most effective would first be getting the customer’s needs to draw baseline from there look into competitors in the field with same background in order to create a better device. Looking into competitors will help improve or…   Read more»

]]> c1257cd870d672ffc76a297fc81bb374 https://medicaldevicecourses.com/activity/p/17699/ Wed, 15 May 2019 21:41:53 -0400 Project manager are the head of the project which are responsible in making sure all departments(Regulatory, Marketing, Manufacture, Quality, Clinical, etc.) complete their deliverables. Project manager creates a schedule for everyone to follow and holds meetings where all department come…   Read more»

]]> 9c79a0dbaf1e902b798ed1a0888659f9 https://medicaldevicecourses.com/activity/p/17698/ Wed, 15 May 2019 21:41:53 -0400 I agree with others that stated that FDA medical devices are classified by how severe the risk is to the public. The risk classification helps in including addition exams/protocals before release the product if it is class 2/3. Class 1…   Read more»

]]> e31cc6583cd2f387dde51c7efec0626d https://medicaldevicecourses.com/activity/p/17697/ Wed, 15 May 2019 21:41:52 -0400 Interpersonal skill is important for every job. It assist in creating connection with customers, researchers, employees, etc. These connections are important because they keep people focused and drawn to the product or idea you are trying to sell out to…   Read more»

]]> 1d499a5788e67f16339fc9535025f9c8 https://medicaldevicecourses.com/activity/p/17634/ Wed, 15 May 2019 21:41:18 -0400 I don’t agree in using unapproved devices because it is a Hail Mary attempt to treat someone. It could cure but there is a high chance that it could cause more pain. Physicians can enlist patients in clinical trials that…   Read more»

]]> 478dbf4bcfd6e7355fb6450aa39bf39a https://medicaldevicecourses.com/activity/p/17632/ Wed, 15 May 2019 21:41:17 -0400 I agree with the group that believes validation and verification should be enforce through out the medical design process. During the design process there are documentation and test studies which project manager must hold meeting where all departments must be…   Read more»

]]> 4f528ed42581b54962b98985b8345ba9 https://medicaldevicecourses.com/activity/p/17618/ Wed, 15 May 2019 21:41:07 -0400 Quality plan is very important because as other stated it helps test the quality of the product that is going to be release to the public. There are so many risk that a new product can have and in order…   Read more»

]]> b1b99f5a726fb703a7a0234c375d8752 https://medicaldevicecourses.com/activity/p/17555/ Wed, 15 May 2019 21:40:35 -0400 Risk management plan is method to reduce any risk a company can suffer. It is a way that the company can avoid/ minimize being sued or even harming the public. Last year I took medical device development and the way…   Read more»

]]> 37f95b2f0f5a9f32436e93506f7584c0 https://medicaldevicecourses.com/activity/p/17543/ Wed, 15 May 2019 21:40:25 -0400 I would definitely agree on a recall because it will be the company’s fault if one of their product device harms a person. The company is responsible of displaying all warning, healthy issues because the product they released, the public…   Read more»

]]> bd103a29fbb48d9a4642345d236098ae https://medicaldevicecourses.com/activity/p/17542/ Wed, 15 May 2019 21:40:25 -0400 This is a tough decision but it will all depend on, will it actually work and help the public because there are projects that will not make it to the public due to malfunction and or delays. There must be…   Read more»

]]> 518440f6c8f8759d6c6f04e60591fda4 https://medicaldevicecourses.com/activity/p/17482/ Wed, 15 May 2019 21:39:54 -0400 I think the ratio should be 60% interpersonal and 40% technical. The reason being is that technical is taught in school. Students are trained how to solve problems and how to do research for their project. However, when it comes…   Read more»

]]> ad8aaae4364820e05d52c88de48112bb https://medicaldevicecourses.com/activity/p/17481/ Wed, 15 May 2019 21:39:53 -0400 It is very important to pick the right members for a project because they must be able to fulfill their task in order to complete the project. The members chosen must be reliable and have friendly communication skills because the…   Read more»

]]> 273d4c6eb4a68993bebf39d4ecce3a7a https://medicaldevicecourses.com/activity/p/17479/ Wed, 15 May 2019 21:39:52 -0400 I think a project manager must have time management and communication skills. The reason being is that for every project there are time limit. Project managements are responsible for meeting all report document deadline from their fellow departments, for example;…   Read more»

]]> 4604455ce2ed46bfbdb27a526afb3751 https://medicaldevicecourses.com/activity/p/17387/ Wed, 15 May 2019 21:39:03 -0400 I agree with everyone that both written and verbal contract are important and that written contract is more powerful than verbal contract unless it is recorded because they can searched and found as evidence. Written and verbal recordings are documented…   Read more»

]]> 2a3532cc0087eb44ff7052b03d480c3f https://medicaldevicecourses.com/activity/p/17380/ Wed, 15 May 2019 21:39:00 -0400 This is good course for getting experience in the start development of medical devices. This course shows how each department work in the development process of devices and what documents are required. Prior to this class I did not know…   Read more»

]]> 7732e77feec28d65935645754d096bb5 https://medicaldevicecourses.com/activity/p/17378/ Wed, 15 May 2019 21:38:59 -0400 The difference between NDA and Patents is that NDA keeps a secret between to people and or companies, while patent provide ownership of the device product. I feel that if you are developing a device you can’t patent it on…   Read more»

]]> 20084810e0e2973706d22844c74a5cdd https://medicaldevicecourses.com/activity/p/17319/ Wed, 15 May 2019 21:38:30 -0400 The way I would create my project group is picking people who I know that will work with well with a team. If I don’t know them, I will look for people that have a high communication skills because communication…   Read more»

]]> 65ab8fbe7cea18e06a7a3a2caab1a4c0 https://medicaldevicecourses.com/activity/p/17316/ Wed, 15 May 2019 21:38:29 -0400 We haven’t had a in person meeting yet but will are scheduled to meet every Thursday. We have been communicating through groupme, text, and by email. All of are documents are being done through google word. As of today we…   Read more»

]]> a3b4e64b2433890e62b4727d63d6aedc https://medicaldevicecourses.com/activity/p/17314/ Wed, 15 May 2019 21:38:28 -0400 I believe that anyone could either middle management or upper management, it will just only depend on their. I would like to be in upper management but unfortunately I don’t have the skill set. I would prefer to work in…   Read more»

]]> e883744fddf399822ba777d17d68b6a8 https://medicaldevicecourses.com/activity/p/17172/ Wed, 15 May 2019 21:37:14 -0400 I agree with everyone that says the error is the non-life cycle process of the risk management meetings. I agree with this because one risk meeting in the beginning of the product development does not clear up the other risk…   Read more»

]]> 9cb4374ab8b62342425007b3a78d5c56 https://medicaldevicecourses.com/activity/p/17166/ Wed, 15 May 2019 21:37:12 -0400 I do agree that labeling is important but not very effective in informing the risk of the medical product being sold. The reason is that some people just read the instruction only, not the warning, which is not good. For…   Read more»

]]> 7482c725d329ff1f0638823eed60750b https://medicaldevicecourses.com/activity/p/17165/ Wed, 15 May 2019 21:37:11 -0400 Every company needs a risk meeting, it is important because all the product that is being produced is for someone or something. We must keep the consumer safe, which is the main focus of the meeting. In the risk meeting,…   Read more»

]]> 908fc447473b6f948863240d934c6ca2 https://medicaldevicecourses.com/activity/p/17104/ Wed, 15 May 2019 21:36:40 -0400 I have not worked for any industry but I did attend design review meeting during my capstone project. It is the time where we discuss the progression of my team design. Are we missing any goals? What did we accomplish…   Read more»

]]> 874f89620053b127637b4446804745fe https://medicaldevicecourses.com/activity/p/17096/ Wed, 15 May 2019 21:36:36 -0400 Design control is very important in marketing product, if design control is not sufficient the product release will be delayed. The reason being is that design control helps check if the product is working as it was intended. Design control…   Read more»

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