https://medicaldevicecourses.com/members/amin-sadig/activity/ Activity feed for amin-sadig. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ed51be09614f557afd78763308ab689d https://medicaldevicecourses.com/activity/p/15948/ Wed, 15 May 2019 19:15:31 -0400 I believe that it depends on the job and the nature of the work since you may not need highly skilled labor for the task and employees may be expendable. sounds harsh but we see this in jobs like technicians…   Read more»

]]> 169fda74bd4fc7ca61922a3772d08aee https://medicaldevicecourses.com/activity/p/15946/ Wed, 15 May 2019 19:15:30 -0400 I don’t believe any information is transferable from 1 trial to another and patient data protection laws make using it without consent impossible. Technology can be used however to expedite patient selection using digital filtering based on responses similar to…   Read more»

]]> 218bb797379ba228d308fa888012eed2 https://medicaldevicecourses.com/activity/p/15800/ Wed, 15 May 2019 19:14:01 -0400 To answer the first question, we need to look at the factors that influence R. Aside from what the others have said, there is also the companies financial situation and overall business goal. If it is a startup with lots…   Read more»

]]> d4c7d87e52390490fca449ef8d548f90 https://medicaldevicecourses.com/activity/p/15650/ Wed, 15 May 2019 19:12:30 -0400 Usually change has a driving factor which comes mainly in the three, not mutually exclusive, flavors; necessity, efficiency, and profitability. In the first situation, change is unavoidable because the product at the moment is either out of spec, fails to…   Read more»

]]> 34c0f9cf35be398c81ac89d02328b30c https://medicaldevicecourses.com/activity/p/15570/ Wed, 15 May 2019 19:07:45 -0400 So as to not be too repetitive, having a third party review certain key documents that you may be bias towards as well as having different technicians perform testing/assembling according to the testing/assembling documents to ensure they are relatively dummy…   Read more»

]]> e60218d43ba3460cf2ce42c1e2ad6a2c https://medicaldevicecourses.com/activity/p/15563/ Wed, 15 May 2019 19:07:41 -0400 The first step is identifying the type of change being requested. It can be to the BOM, Labeling, paperwork, testing procedures, storing procedures, sterilization procedures, disposing procedure, packaging, etc. Depending on the type of change requested the factors to consider…   Read more»

]]> 2f64766b0fd13fe40133b73c134eb98b https://medicaldevicecourses.com/activity/p/15431/ Wed, 15 May 2019 19:06:19 -0400 One thing to remember is that most if not all companies already have an “Approved Vendor List”, or AVL, for all different products and services that your company may need. The companies on the list are audits in some form…   Read more»

]]> 0007e97e3c6c1f5f68c189a0829d1b84 https://medicaldevicecourses.com/activity/p/15428/ Wed, 15 May 2019 19:06:17 -0400 One thing that we need to remember is that successful project execution is not always the end goal, from a corporations standpoint, the end goal is the best way to secure financial revenue and fulfill the commitments made to make…   Read more»

]]> 654ffab1fe3ae4fc9efd7162162892e1 https://medicaldevicecourses.com/activity/p/15426/ Wed, 15 May 2019 19:06:10 -0400 If by project execution you mean the execution plan/phase of the project, then it is safe to assume that the other phases have been completed. At this point in the project progression all or a majority of background research/ investigations…   Read more»

]]> 230060b1c357f6f46937c1bcb5a2d057 https://medicaldevicecourses.com/activity/p/15326/ Wed, 15 May 2019 19:05:15 -0400 I Agree but the first step should always be understanding the scope of the project because without that you will find new components that need procedures or additional tasks you didn’t account for. The step should also have some form…   Read more»

]]> 496489e0a82a7718f6088101996ead01 https://medicaldevicecourses.com/activity/p/15324/ Wed, 15 May 2019 19:05:14 -0400 For the given Simulation, the glaring initial problem is the solubility of the carrier in water. while I agree with the previous statements, we need to have a plan of action before we can put them into a Gantt or…   Read more»

]]> f3021bdb381171d43ef919bd1e66c2ef https://medicaldevicecourses.com/activity/p/15239/ Wed, 15 May 2019 19:04:20 -0400 This depends on the financial stability of the company and how important the project you are working on is. If the project is critical and the time restraints are inflexible then going back to a previous phase would allocate resources…   Read more»

]]> 18e28b374404e5d8cd0b394f87d7f186 https://medicaldevicecourses.com/activity/p/15237/ Wed, 15 May 2019 19:04:19 -0400 smk45 took the words out of my mouth by mentioning scope. Fully understanding the scope of the project is the first most important thing in reducing risk because unfavorable results can cause delays that can be accounted for when setting…   Read more»

]]> da1dc4b5ba4c6382ba7f6c305ba1f9d4 https://medicaldevicecourses.com/activity/p/15104/ Wed, 15 May 2019 19:03:04 -0400 You will find that the M&C is highly correlated to the a properly defined scope. Many of you have mentioned capstone, and I am sure that as you began actually building the product you realized that your understanding of the…   Read more»

]]> 2a758260268b39039f32f6afa1d6fe4d https://medicaldevicecourses.com/activity/p/15101/ Wed, 15 May 2019 19:03:03 -0400 While it is a terrible practice to define something with itself Project scope management is the management of the scope of the project. This is important at several phases within a project from its genesis all the way to its…   Read more»

]]> 0f6b3361c29d9c2cf1e4992159ebb4f4 https://medicaldevicecourses.com/activity/p/15007/ Wed, 15 May 2019 19:02:07 -0400 i don’t think using the pharmaceutical industry as a comparison is a good idea since drugs like thalidomide were allowed on the market and cigarettes caused “no health issues” for such a long time. I believe that the government should…   Read more»

]]> b10f3701da13a9de41a9444e8aca8bbf https://medicaldevicecourses.com/activity/p/14997/ Wed, 15 May 2019 19:02:03 -0400 To address this question, quite a few factors have to be considered and I believe the answer is not as simple as a yes or no. Among the factors to consider are the location and availability of supplies that can…   Read more»

]]> b4e6962033a8e367e3da5f6551e0fc6b https://medicaldevicecourses.com/activity/p/14866/ Wed, 15 May 2019 19:00:54 -0400 While it is easy to say make regulations elastic to do everything they intended to do without hindering innovation, practically insuring that everything is done to prevent a critical failure once on the market and deregulating as a means of…   Read more»

]]> 5e5ddd3b7d1d3e43ca95b92065e16c2e https://medicaldevicecourses.com/activity/p/14857/ Wed, 15 May 2019 19:00:49 -0400 Since I don’t want to echo too much of what everyone said I’ll add what I think is not said. While leadership is a key role it is vague, and charisma is not really needed while it can help with…   Read more»

]]> 0fdb59ef9249b1b5be84c35d7c03b511 https://medicaldevicecourses.com/activity/p/14849/ Wed, 15 May 2019 19:00:45 -0400 Any major changes, in this case material composition changes, needs to be reported to the FDA. In the event that it is a novel material or a novel use of the material, in vivo studies will have to be done…   Read more»

]]> 601a01f9a99201d3d8ebc2cd658087bd https://medicaldevicecourses.com/activity/p/14734/ Wed, 15 May 2019 18:59:36 -0400 For clarification purposes. The scamming that I was referring to is with regards to the fact that many of the treatment options available with acupuncture and electroacupuncture are not proven to be statistically significantly different than placebo acupuncture or sham…   Read more»

]]> 9c17b5d071e72b2b8e25b2fb489aa8c7 https://medicaldevicecourses.com/activity/p/14714/ Wed, 15 May 2019 18:59:25 -0400 While I am not well versed in understanding the rationale of the FDA for determining the PMOA of a device, in this particular case i believe that it is a device. The rationale being that the drug component of the…   Read more»

]]> 9df1cdb6f97645094b2ab5bece021e80 https://medicaldevicecourses.com/activity/p/14599/ Wed, 15 May 2019 18:58:22 -0400 Due to an error and not being able to make a new forum I am posting here. While the topic is related to Fitbit, the question is not the same. Should how we use a device define it? When determining…   Read more»

]]> f44d539cae177ec035676e5e9af85623 https://medicaldevicecourses.com/activity/p/14593/ Wed, 15 May 2019 18:58:19 -0400 I think the biggest issue here is what we determine as “Success”. If by success we mean climbing the ladder to eventually becoming a high-ranking official in a company versus landing a good paying job and being able to convince…   Read more»

]]> a1d2eccb6fae720cd9f7ce48e635bbf4 https://medicaldevicecourses.com/activity/p/10733/ Wed, 15 May 2019 16:36:03 -0400 Throughout the semester we have been exposed to different qualities a manager needs to have. Among which are interpersonal skills, organization, and crisis management. I was wondering how the qualities you currently have correlate to the qualities you need as…   Read more»

]]> 12d4e97171fde3596bb3d27b171372ff https://medicaldevicecourses.com/activity/p/10732/ Wed, 15 May 2019 16:36:03 -0400 One of the major problems that I found with my approach to simulations throughout the semester is the fact that I tunnel vision and close of other options once I go down a route until my current thought process critically…   Read more»

]]> ae747d629fda22a9c0270dd4c2f17840 https://medicaldevicecourses.com/activity/p/10724/ Wed, 15 May 2019 16:35:55 -0400 Understanding ourselves and our natural inclinations is an important to improving ourselves. Do I naturally find faults in others or see what good they do? Understanding this will make you aware of what you don’t do, so you can try…   Read more»

]]> 828d23b65627bf315728631e2f0330e0 https://medicaldevicecourses.com/activity/p/10717/ Wed, 15 May 2019 16:35:52 -0400 As many of us know, there is a lot of paperwork involved in most processes within projects whether it is for monitoring or documentation purposes and individual companies have different Quality Management Systems. While it is easy to say make…   Read more»

]]> 99957d5be95030a72fe0bc5250263ce1 https://medicaldevicecourses.com/activity/p/10716/ Wed, 15 May 2019 16:35:51 -0400 As we all know specifications are essential for any product and not only affect the validation and verification of a product but everything that is the product. We saw in the minisim this week one of the set backs of…   Read more»

]]> 7d87e02a6922d112d524a3c27b73a72c https://medicaldevicecourses.com/activity/p/10704/ Wed, 15 May 2019 16:35:45 -0400 In the most recent simulation, we saw a situation where marketing went off on their own and their actions directly affected the timeline/schedule of the hydrosurf project. When making a schedule and timeline as PM, such curve balls can occur…   Read more»

]]> cc981d308ef8dabc4967148b7f9cb960 https://medicaldevicecourses.com/activity/p/10697/ Wed, 15 May 2019 16:35:41 -0400 As you may have seen this week, you can see how your cost is aligning with budget and estimated cost using the techniques learned this week. However, though this may seem obvious, the tasks distributed throughout the project do not…   Read more»

]]> c6e3ccbfb5672d034aa3a4b9928a314f https://medicaldevicecourses.com/activity/p/10673/ Wed, 15 May 2019 16:35:29 -0400 From as early as the mini sim we were told to consider outside factors such as vacation times for inspectors when planning a schedule so we don’t get delayed unnecessarily. Because the job of a PA is group centric and…   Read more»

]]> 84b81a449faf2bc8967f72f03705293e https://medicaldevicecourses.com/activity/p/10665/ Wed, 15 May 2019 16:35:25 -0400 We learned a lot about scheduling and task delegation this week and one major question arose. If the PM changes at different phases of a project (beginning, mid, near conclusion), and the an error in the scope is identified in…   Read more»

]]> ae132a5fa9c9a859b83d5a23a6f9e41b https://medicaldevicecourses.com/activity/p/10657/ Wed, 15 May 2019 16:35:20 -0400 As many of you know, government regulations release update periodically. Sometimes its simple grammar and spelling fixed as well as quality of life wording fixes but other times, it is the inclusion of new regulations and requirements. What do you…   Read more»

]]> 65c16ae5886694828b61a56b236632c1 https://medicaldevicecourses.com/activity/p/10629/ Wed, 15 May 2019 16:35:06 -0400 There are conflicting studies on the effects of acupuncture especially proving efficacy against a placebo. While it is currently approved for pain treatments the current services provided go much farther. I have had a growing interest in the field, and…   Read more»

]]> dd93ca593dbc261443643be7b9da5793 https://medicaldevicecourses.com/activity/p/10628/ Wed, 15 May 2019 16:35:05 -0400 An interesting issue arose at the last BME seminar regarding TJA total joint arthroplasty, where joint replacement surgeries advertised individuals doing high intensity or extreme sports 129 days after surgery. The sports include skiing, water boarding, dirt biking etc. While…   Read more»

]]> 4e29903cdfc28bb9fca2f4369df5228e https://medicaldevicecourses.com/activity/p/10616/ Wed, 15 May 2019 16:34:59 -0400 I was thinking about the mock simulation that was done in the in person class on Friday and wanted to hear the thoughts of others on the decision making mechanism those of you with years of industry experience have with…   Read more»

]]> 8155cef25711aa4ac0f93343490ae6b4 https://medicaldevicecourses.com/activity/p/7623/ Tue, 01 May 2018 03:23:28 -0400 Throughout the semester we have been exposed to different qualities a manager needs to have. Among which are interpersonal skills, organization, and crisis management. I was wondering how the qualities you currently have correlate to the qualities you need as a manager and how you plan on cultivating your deficiencies?
I personally intend to have…[Read more]

]]> 0 794a9fb4513bb8258b528078152d6384 https://medicaldevicecourses.com/activity/p/7622/ Tue, 01 May 2018 01:56:19 -0400 One of the major problems that I found with my approach to simulations throughout the semester is the fact that I tunnel vision and close of other options once I go down a route until my current thought process critically fails.
I was wondering how the rest of you have managed to balance focusing in on the issue and maintaining an eagles eye view…[Read more]

]]> 0 41b6c5cc0c3343177672dd82417bd8e1 https://medicaldevicecourses.com/activity/p/7496/ Mon, 23 Apr 2018 04:01:22 -0400 I believe that it depends on the job and the nature of the work since you may not need highly skilled labor for the task and employees may be expendable. sounds harsh but we see this in jobs like technicians and people on the manufacturing floor. training may be a pain but a few days will get you someone as good as the last. Retaining talent for…[Read more]

]]> 0 ca52d49cadb934c6ea66da85802b1e52 https://medicaldevicecourses.com/activity/p/7494/ Mon, 23 Apr 2018 03:58:06 -0400 I don’t believe any information is transferable from 1 trial to another and patient data protection laws make using it without consent impossible. Technology can be used however to expedite patient selection using digital filtering based on responses similar to job recruiting sites and resumes. Certain psychological tests can be done to reduce for…[Read more]

]]> 0 73fefdeacf187575d86ec5442a31806b https://medicaldevicecourses.com/activity/p/7489/ Mon, 23 Apr 2018 03:45:08 -0400 Understanding ourselves and our natural inclinations is an important to improving ourselves. Do I naturally find faults in others or see what good they do? Understanding this will make you aware of what you don’t do, so you can try to compensate since both important. Not all employees are the same. Some have qualities that lean towards x or y and…[Read more]

]]> 0 9905f8cf10fd692dd3d994beb169140a https://medicaldevicecourses.com/activity/p/7326/ Mon, 16 Apr 2018 03:15:49 -0400 To answer the first question, we need to look at the factors that influence R. Aside from what the others have said, there is also the companies financial situation and overall business goal. If it is a startup with lots of debt then the R value will be much higher since time is critical factor that will determine if the company stays afloat but…[Read more]

]]> 0 d23b00cbf8332d3e39472c627c773557 https://medicaldevicecourses.com/activity/p/7320/ Mon, 16 Apr 2018 02:51:35 -0400 As many of us know, there is a lot of paperwork involved in most processes within projects whether it is for monitoring or documentation purposes and individual companies have different Quality Management Systems. While it is easy to say make documentation enough to be sufficient in recording all necessary information while not being too much that…[Read more]

]]> 0 cbaf72dd205fe8c4c61c8bd3391b9762 https://medicaldevicecourses.com/activity/p/7316/ Mon, 16 Apr 2018 02:39:20 -0400 As we all know specifications are essential for any product and not only affect the validation and verification of a product but everything that is the product. We saw in the minisim this week one of the set backs of the high specificity in a requirement. Should specifications reflect the limits to which any individual component can be to function…[Read more]

]]> 0 db6c7c93421ab843c022827a92cd8ea1 https://medicaldevicecourses.com/activity/p/7129/ Mon, 02 Apr 2018 02:13:39 -0400 In the most recent simulation, we saw a situation where marketing went off on their own and their actions directly affected the timeline/schedule of the hydrosurf project. When making a schedule and timeline as PM, such curve balls can occur at anytime. They can change the deadline for completion to be sooner than initially intended, change a…[Read more]

]]> 0 81437e9baec4d32a4216e91d2f7968ac https://medicaldevicecourses.com/activity/p/7128/ Mon, 02 Apr 2018 02:04:01 -0400 Usually change has a driving factor which comes mainly in the three, not mutually exclusive, flavors; necessity, efficiency, and profitability. In the first situation, change is unavoidable because the product at the moment is either out of spec, fails to meet a required standard, or has a change in risk(usually an increase) that is too great for…[Read more]

]]> 0 4501ba4d6d6f503102b037a2922b4927 https://medicaldevicecourses.com/activity/p/7023/ Mon, 26 Mar 2018 03:54:42 -0400 So as to not be too repetitive, having a third party review certain key documents that you may be bias towards as well as having different technicians perform testing/assembling according to the testing/assembling documents to ensure they are relatively dummy proof since the worst case scenario could be failure of a product while under…[Read more]

]]> 0 78e02b654a42fa70d41ac2132cbfd822 https://medicaldevicecourses.com/activity/p/7018/ Mon, 26 Mar 2018 03:41:03 -0400 As you may have seen this week, you can see how your cost is aligning with budget and estimated cost using the techniques learned this week. However, though this may seem obvious, the tasks distributed throughout the project do not have a uniform cost and using EV in projects with highly skewed cost distributions will results in either false…[Read more]

]]> 0 19588460c621c02dafb17ebc83e3c113 https://medicaldevicecourses.com/activity/p/7015/ Mon, 26 Mar 2018 03:32:35 -0400 The first step is identifying the type of change being requested. It can be to the BOM, Labeling, paperwork, testing procedures, storing procedures, sterilization procedures, disposing procedure, packaging, etc. Depending on the type of change requested the factors to consider will obviously change. some of the changes may come from revised…[Read more]

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