https://medicaldevicecourses.com/members/naglaa-hemida/activity/ Activity feed for Naglaa Hemida. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 1c2d413788daf3153d4438cd12639745 https://medicaldevicecourses.com/activity/p/24099/ Sun, 28 Nov 2021 22:37:57 -0500 This training has been quite beneficial in showing folks what might be expected of them in the real world. It was interesting to observe the many stages of medical device development and what is required at each level. Even if…   Read more»

]]> f660aaa3b8be345be10b7e53e04d4dbf https://medicaldevicecourses.com/activity/p/24098/ Sun, 28 Nov 2021 22:36:16 -0500 It seems logical to me that these rules are in place. You could think it’s a little too limiting, but they need to be there. My father was a doctor in India, and he told me stories of the perks…   Read more»

]]> bfa29640754b8a358362c2f648757694 https://medicaldevicecourses.com/activity/p/24097/ Sun, 28 Nov 2021 22:34:16 -0500 It seems logical to me that these rules are in place. You could think it’s a little too limiting, but they need to be there. My father was a doctor in India, and he told me stories of the perks…   Read more»

]]> 013bb0c7c339c682427b3bf27eea00d4 https://medicaldevicecourses.com/activity/p/24041/ Sun, 21 Nov 2021 23:32:35 -0500 When deciding which organizational structure is ideal for a company, the size of the company must be taken into account. The organizational structure largely impacts departmental communication, which in turn determines a project’s success. The matrix structure appears to be…   Read more»

]]> 3557090aa0a7f41db455f68f3def60d0 https://medicaldevicecourses.com/activity/p/24040/ Sun, 21 Nov 2021 23:29:02 -0500 I would suggest establishing the startup company as a functional organization from the outset. As stated in the lecture, this type of structure is appropriate for small businesses, and the benefits are obvious: Because individuals with similar abilities and knowledge…   Read more»

]]> 2894c5d6daf057fae4f5dfc120e87ec3 https://medicaldevicecourses.com/activity/p/24039/ Sun, 21 Nov 2021 23:25:39 -0500 It’s critical to hire the proper personnel for a successful project team. Professional performance, as well as personal traits, must be evaluated. We often have little control over who joins our team. If at all possible, we should select knowledgeable…   Read more»

]]> c2a37a170d5f79cf4b1e2b6dac77727d https://medicaldevicecourses.com/activity/p/23999/ Mon, 15 Nov 2021 00:31:52 -0500 The prototype system is being exploited in product development since it does not consider important risk factors. I learned about this risk management blunder at the organization where I work, and I’m concentrating on the prototype issue here. The product…   Read more»

]]> 94f7ea00b27618e510be5bc2c9a396b6 https://medicaldevicecourses.com/activity/p/23998/ Mon, 15 Nov 2021 00:26:32 -0500 Additional criteria should be considered when calculating the risk value. In most cases, EDP audit teams search for both threats and vulnerabilities in corporate information systems. This usually takes some time to assess. The context in which the risk analysis…   Read more»

]]> bdfb1db4a077ec6ff90c71a028ba2357 https://medicaldevicecourses.com/activity/p/23997/ Mon, 15 Nov 2021 00:23:09 -0500 In my perspective, risk management starts with end-user training and education. It is incumbent to a corporation to educate the end-user population to the best of their ability once they have done all possible to provide a safe and effective…   Read more»

]]> ad54f075747bec8ef37a88cd0551b9be https://medicaldevicecourses.com/activity/p/23955/ Mon, 08 Nov 2021 01:52:07 -0500 Validation is necessary to verify whether the gadget satisfies the user’s demands and is fit for its intended purpose; it also aids the corporation in determining whether they are building the proper item. The FDA places a strong emphasis on…   Read more»

]]> 94d28d15e1124f6892325c75f2d66acd https://medicaldevicecourses.com/activity/p/23954/ Mon, 08 Nov 2021 01:43:08 -0500 One of the benefits of the DID document is that it gives you a broad idea of how the finished product will look. This is essentially a mental image of what you and the department think the design will be….   Read more»

]]> f94077ca7dacab5b4fdc4744d586c197 https://medicaldevicecourses.com/activity/p/23953/ Mon, 08 Nov 2021 01:39:18 -0500 The Turkish Medicines and Medical Devices Agency is in charge of design control in Turkey. It adheres to ISO 13485 and ISO 9001 standards. Medical devices in Turkey must be CE-marked and registered in the Turkish Ministry’s Online Database of…   Read more»

]]> 694df88bf7e729ecdb37ba96bc8eaa42 https://medicaldevicecourses.com/activity/p/23912/ Mon, 01 Nov 2021 05:03:09 -0400 One thing I’ve learned is that no matter how much planning you do, some situations are beyond your control. In my field, for example, we must do multiple pre-clinical experiments, which must be coordinated with the trial site. However, due…   Read more»

]]> e4b96ee5005d3710edabeb04c16ab068 https://medicaldevicecourses.com/activity/p/23911/ Mon, 01 Nov 2021 04:59:52 -0400 The FDA mandates design controls, which are used to assure traceability of issued products. The notion is that if a released product has a flaw that interferes with its operation and has an impact on the consumer, the entire history…   Read more»

]]> 1d7f7a395fab208e2893af309f9b193b https://medicaldevicecourses.com/activity/p/23910/ Mon, 01 Nov 2021 04:52:13 -0400 Meeting minutes are indeed a significant element of the device’s design change and development process. The value of meeting minutes varies depending on where you are in the medical device development cycle. When design changes or design review meetings take…   Read more»

]]> d1ed223d5c9cdf7c3355adac6f057b8b https://medicaldevicecourses.com/activity/p/23829/ Mon, 25 Oct 2021 00:03:06 -0400 The benefit of a clinical trial, in my opinion, is being able to witness the result of years of study. To get to a clinical study, a lot of data has to be gathered, and this is where it all…   Read more»

]]> 442b2c23141de40d09d0eb55ae611991 https://medicaldevicecourses.com/activity/p/23828/ Sun, 24 Oct 2021 23:51:40 -0400 Placebo trials are essential because they provide a data point that may be compared to the findings of other experiments. A placebo study can be likened to a control experiment in terms of setup. This guarantees that there is a…   Read more»

]]> 73919409a059c47b370a77554464dbf7 https://medicaldevicecourses.com/activity/p/23827/ Sun, 24 Oct 2021 23:43:29 -0400 In my point of view, double-blind studies are more accurate since they provide a valid baseline for the experiment. The lecture used the double-blind multi-center research as an example. Dr. Simon demonstrates how a doctor’s competency influenced the study, and…   Read more»

]]> 119bbe4e539bf3a9f15cad6053ed72fd https://medicaldevicecourses.com/activity/p/23769/ Mon, 18 Oct 2021 06:46:53 -0400 Multi-channel analytics is currently one of the strategies in use. Multiple pieces of data from various sources are integrated and stored together in this procedure. Businesses then utilize this data to communicate with customers via Apps, the internet, mobile phones,…   Read more»

]]> 67d99ff1ddd6b9f3d035ffd4232e2faf https://medicaldevicecourses.com/activity/p/23768/ Mon, 18 Oct 2021 06:44:45 -0400 Emotional intelligence is the capacity to recognize and control one’s own and others’ emotions. EI is someone I admire. The impact of people’s emotions on job efficiency is significant. To illustrate, if a worker is in a bad mood, he/she…   Read more»

]]> 0a148d2ab5c3041dd2796ac7ccf3dc93 https://medicaldevicecourses.com/activity/p/23767/ Mon, 18 Oct 2021 06:30:33 -0400 The color red is frequently utilized when creating a brand for a food company or franchise because, according to certain studies, the color red influences client decisions by generating more impulsive emotions and demands. Of course, the target term that…   Read more»

]]> fa8a592d71fa1c999be1be2abe074fac https://medicaldevicecourses.com/activity/p/23681/ Mon, 11 Oct 2021 00:10:34 -0400 I might decide on a confined partnership corp. due to the fact being a confined associate places a difficulty on legal responsibility with recognize each to ability proceedings and money; the confined associate is handiest going to be responsible for…   Read more»

]]> b9f07812b502af420fbe0f3c6d07862d https://medicaldevicecourses.com/activity/p/23679/ Sun, 10 Oct 2021 23:54:59 -0400 In the case of a sole proprietorship, the owner is fully responsible for how the business works and what is allowed and what is not. The owner is free to make any changes he sees fit to help his business…   Read more»

]]> 1dfdd1588411544345c95bc5bd5c96b9 https://medicaldevicecourses.com/activity/p/23678/ Sun, 10 Oct 2021 23:50:54 -0400 In my opinion, graduates applying for positions in a related field don’t necessarily pay attention to whether the company is a limited partnership or a corporation. In today’s world it is very difficult to get a job without having an…   Read more»

]]> ebfe2af46dd38925a30c3fd1a04da945 https://medicaldevicecourses.com/activity/p/23584/ Sun, 03 Oct 2021 19:18:27 -0400 A QA department’s document control is intended to ensure that all project paperwork is in order, so that when the FDA or another entity arrives for an audit, for example, the firm team is ready to demonstrate that they are…   Read more»

]]> 2d1fd063c1dda0f7d9bfc387936b10d1 https://medicaldevicecourses.com/activity/p/23583/ Sun, 03 Oct 2021 19:09:13 -0400 A manager overseeing the process development would be in charge of quality assurance, which would be accomplished through audits, checklists, and standard procedures. Quality assurance could be viewed as a more proactive approach to fault prevention. Quality control, on the…   Read more»

]]> 302f284e52deadd7fcf63e100d47e718 https://medicaldevicecourses.com/activity/p/23582/ Sun, 03 Oct 2021 19:03:19 -0400 At the most successful and consistent firms, the quality department is embedded deep throughout the organization’s structure. This means that, while there is a dedicated quality department, there must be a strong focus on integrating these workers and their procedures…   Read more»

]]> c3c26f954baf6bd97935986276c71ecd https://medicaldevicecourses.com/activity/p/23501/ Mon, 27 Sep 2021 02:46:47 -0400 Trump’s new budget proposal, which calls for a two-billion-dollar raise in FDA user fees, has certain positives, but it also has some disadvantages. The enhanced benefits for taxpayers would be one of the most significant advantages of this shift. There…   Read more»

]]> a9e2ff34e707d00c4a4ad16017e1e6a6 https://medicaldevicecourses.com/activity/p/23500/ Mon, 27 Sep 2021 02:21:22 -0400 Insulin Pump is a tool that helps inject the patient with insulin based on the patient’s blood glucose level. The device monitors the glucose level in the patient’s blood periodically and adjusts the amount of insulin injected based on the…   Read more»

]]> 46c330d2b318db2ce701ef4a0c28a9fc https://medicaldevicecourses.com/activity/p/23499/ Mon, 27 Sep 2021 01:35:09 -0400 We agree that the FDA regulation saves lives by ensuring the safety and efficacy of the medical device. However, it still slows down the process of commercializing the medical device. Aside from having strict rules to approve the medical device,…   Read more»

]]> ee3089f04439f0c259ccbe35abc0f0a5 https://medicaldevicecourses.com/activity/p/23378/ Sat, 18 Sep 2021 23:15:11 -0400 Project management takes place in every step of the preclinical research from setting the deadline, budget, and schedule to choosing the team that will work on the project. As you mentioned it is an obvious yes, planning is an essential…   Read more»

]]> 0556a36f6f38cf2aa1bc310c047b831d https://medicaldevicecourses.com/activity/p/23377/ Sat, 18 Sep 2021 22:50:56 -0400 The choice of the material can affect the duration and cost of the device in terms of regulation. Choosing a new biomaterial that was not used before will increase the testing duration for the biomaterial to test its compatibility with…   Read more»

]]> 6ab116e73c7dadfa24b78694fbc03bd9 https://medicaldevicecourses.com/activity/p/23376/ Sat, 18 Sep 2021 22:31:25 -0400 In industry, even though there are fewer projects to work on, schedules are tight, and deadlines are not to be missed, not finishing a project is not an option. On the other hand, We learned that the professors are the…   Read more»

]]> 4b823159bc6e32ae08e4c16273c40d4f https://medicaldevicecourses.com/activity/p/23375/ Sat, 18 Sep 2021 21:44:20 -0400 954b6e2d8396526bef624261491630fa https://medicaldevicecourses.com/activity/p/23374/ Sat, 18 Sep 2021 21:44:18 -0400 76c6e63cf076ffa078e5d8b3b16609aa https://medicaldevicecourses.com/activity/p/23373/ Sat, 18 Sep 2021 21:44:16 -0400 bf16a3eafcc9648047a04aef52a8c45f https://medicaldevicecourses.com/activity/p/23259/ Sat, 11 Sep 2021 06:51:33 -0400 To design a successful project, it is essential to plan the schedule to prevent missing milestones. I see it is critical to estimate the duration of the task not only to prevent missing milestones but also to prevent the project…   Read more»

]]> d219ed3dedec77468bdef9976edc25a7 https://medicaldevicecourses.com/activity/p/23258/ Sat, 11 Sep 2021 06:42:28 -0400 To accommodate for a delayed step or missing a milestone, I found that working on multiple steps simultaneously could make up for the lost time. As it was mentioned in the lecture of ” Project Management 101,” a Gantt Chart…   Read more»

]]> 2c914de3ff3500258e3d905e923d169b https://medicaldevicecourses.com/activity/p/23239/ Fri, 10 Sep 2021 09:58:47 -0400 From my experience working in the industry, a missed milestone is looked at as a failure in the Initiation and planning phases of the project. As we discussed in lecture one, working on a tight schedule is a part of…   Read more»

]]> 78d908c4f8de6fc733d929a6adc43b88 https://medicaldevicecourses.com/activity/p/23135/ Fri, 03 Sep 2021 23:57:57 -0400 Being overqualified for a position has some clear advantages such as, learning more on the job in a small period, make connections, and proving yourself worth for the company’s promotions. furthermore, it can help climbing the corporate ladder quicker. On…   Read more»

]]> 6b4cee067edc1b52e742b905bbdf694a https://medicaldevicecourses.com/activity/p/23133/ Fri, 03 Sep 2021 23:34:31 -0400 I think NJIT needs to add more practical classes such as this one; as Dr. Simon mentioned in the lecture “The Story Behind this Course,” it is a shock graduating school and finding yourself not prepared for the market.We can…   Read more»

]]> 9bb83035f5a561d83db54cf6f8384943 https://medicaldevicecourses.com/activity/p/23132/ Fri, 03 Sep 2021 23:04:06 -0400 We agree that both Academia and Industry have pros and cons; it depends on the person seeking to work in the field to see what is more suitable for their personality. A pro in my point of view, could be…   Read more»

]]> 9c1fb4c8ebc2cf40de76a9f1b54c16e5 https://medicaldevicecourses.com/activity/p/22395/ Mon, 03 May 2021 03:12:06 -0400 f3096443f8cf8d0a91b97c6a7d7913af https://medicaldevicecourses.com/activity/p/22394/ Mon, 03 May 2021 03:12:01 -0400 57bc4f8b0900e8056a11bbbc0b9f4ba1 https://medicaldevicecourses.com/activity/p/22393/ Mon, 03 May 2021 03:11:58 -0400 289e30edad0edb8a232da14a14190881 https://medicaldevicecourses.com/activity/p/22392/ Mon, 03 May 2021 03:11:53 -0400 2d9001de4fddc3fb30f35618d2330988 https://medicaldevicecourses.com/activity/p/22391/ Mon, 03 May 2021 03:11:48 -0400 77d2c9974879e8a204f167f880dea939 https://medicaldevicecourses.com/activity/p/22390/ Mon, 03 May 2021 03:11:44 -0400 742b9d374ff15a1ef02efcda247130be https://medicaldevicecourses.com/activity/p/22389/ Mon, 03 May 2021 03:11:18 -0400 From the last simulation, the project had an issue because of limited backup vendors, we have touched on the same issue on the forth mini-simulation as well. Even though the pouch  met the required dimensions for the device. Some of…   Read more»

]]> 350765d17a349707fbb887ed007b00f7 https://medicaldevicecourses.com/activity/p/22388/ Mon, 03 May 2021 03:06:06 -0400 Posted by: @devarshi-joshi As we all know this the last lecture I would like that everyone should give their inputs saying how this class was helpful and how will it help them in future. According to me i believe that…   Read more»

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