https://medicaldevicecourses.com/members/mark-abdelshahed/activity/ Activity feed for Mark William. Fri, 24 Apr 2026 21:40:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 79b27a56f39fac504440f6d3712d3c61 https://medicaldevicecourses.com/activity/p/22329/ Tue, 27 Apr 2021 23:18:34 -0400 What I like the most about this class is the interactive part of it with all the simulations. The simulations gave the class a lot more value rather than just having the academics part of the course. We need to…   Read more»

]]> e22f871a559da90f27d9cdaeb28e1c29 https://medicaldevicecourses.com/activity/p/22328/ Tue, 27 Apr 2021 23:02:53 -0400 If you are talking about priorities as goals then yeah for sure a project can have more than one priority. A project can simply start as part of a manufacturing update; some machinery can be old and due for a…   Read more»

]]> 450518bf6ec851c514a570fc0ac5467b https://medicaldevicecourses.com/activity/p/22327/ Tue, 27 Apr 2021 22:49:14 -0400 I agree; I personally would like to start as an engineer for a couple of years first then move to management. It is good to apply the skills and knowledge obtained from school in an engineering position first to learn…   Read more»

]]> 9afe2aebeecbaa658e4175576f445576 https://medicaldevicecourses.com/activity/p/22236/ Wed, 21 Apr 2021 23:27:34 -0400 Limited recognition and praise and exciting challenging work are connected in a way. In my opinion the number one reason why people leave is not feeling like they are learning anything new. After doing the same thing for two or…   Read more»

]]> aa7e451b5c33d9e3d5d6ff84dd26cd48 https://medicaldevicecourses.com/activity/p/22231/ Wed, 21 Apr 2021 23:01:36 -0400 I would choose to be a part of the Regulatory group. I believe that all those roles are important to have a successful project team, however, Regulatory seems the most important, even though it does not include a lot of…   Read more»

]]> 171a542c8c2bdd118ef48950554c85b3 https://medicaldevicecourses.com/activity/p/22230/ Wed, 21 Apr 2021 22:48:54 -0400 Motivation is for me is mostly words of appreciation. Lately at work I have been overwhelmed with many projects that have a very tight timeline, and studying next to my full time job has not been giving me any time…   Read more»

]]> dd30acdc243102928cdd82f9206451d6 https://medicaldevicecourses.com/activity/p/22111/ Tue, 13 Apr 2021 22:28:11 -0400 Usually in the two weeks that the team member notifies the team that he is leaving, he would be responsible to teach another member from the same function everything about the project and bring that person up to speed in…   Read more»

]]> a54e974d1c180552a381a9759865cabb https://medicaldevicecourses.com/activity/p/22110/ Tue, 13 Apr 2021 22:14:44 -0400 Reactive management is very details oriented in order to monitor and review every single task and step throughout the project. I feel like reactive management is somewhat necessary for the progress of the project but to a certain extent. I…   Read more»

]]> 28585c9402a7fad952ef125d5845e0eb https://medicaldevicecourses.com/activity/p/22109/ Tue, 13 Apr 2021 22:04:17 -0400 This is a very typical situation that happens all the time in the industry. Often times there are some reworks to the organization whether in a department or in a project team. Some project team members are usually assigned a…   Read more»

]]> 5a08001873770a9a77ff1d50c86c9124 https://medicaldevicecourses.com/activity/p/22020/ Wed, 07 Apr 2021 23:13:18 -0400 Project cost always changes with time and that is why there is always a capital or a budget for each project that would give some buffer to that cost increase. Cost always increases if the project is dragging for whatever…   Read more»

]]> 36f6f63df39a1cf1c51b598c1ba30062 https://medicaldevicecourses.com/activity/p/22019/ Wed, 07 Apr 2021 22:57:00 -0400 all those factors definitely play a role in the success of any project.  1) Agreeing on the project goals is essential in order to avoid scope creep. The whole team has to be aligned on the goals in order to…   Read more»

]]> e1a1a8d1a55782f664db355c2a3db2a3 https://medicaldevicecourses.com/activity/p/22018/ Wed, 07 Apr 2021 22:39:00 -0400 This is a very typical situation in the medical devices field. The ideal solution for this issue is to spend more time in the research/initiation phase in order to gather all the information needed to launch the project. For the…   Read more»

]]> d38c7c1ffc3f9aae7af73358e0e25a77 https://medicaldevicecourses.com/activity/p/21876/ Sat, 27 Mar 2021 01:21:13 -0400 In this case, validation would be sufficient to move forward with the implementation of the new instrument. In any change control process, each function has a representative that assesses the change and determines what is needed. When other factors play…   Read more»

]]> 8118b0f5244978f96f26fb11343faa51 https://medicaldevicecourses.com/activity/p/21875/ Sat, 27 Mar 2021 01:09:17 -0400 Missing a milestone is very normal nowadays for many reasons that can be controlled or cannot be avoided sometimes. The first thing that has to be done is investigating why the milestone was missed. Based on the investigation, the team…   Read more»

]]> e8a337d62956a0b6080b0f8a298c0918 https://medicaldevicecourses.com/activity/p/21874/ Sat, 27 Mar 2021 00:55:47 -0400 Most of the time, tasks are done or executed in parallel in order to shorten the overall timeline of the project and get to the launching phase faster. If all tasks are done like a chain then the project will…   Read more»

]]> 755986a749baa15095488fb20d70e6d4 https://medicaldevicecourses.com/activity/p/21638/ Thu, 11 Mar 2021 23:18:29 -0500 It is never very obvious why the project failed and it can be because of many reasons. Choosing the right people for the project is definitely necessary; someone can be very skilled and knowledgeable in the R&D activities including testing…   Read more»

]]> d257c3b6a5258d8e67f54096b8d8ae30 https://medicaldevicecourses.com/activity/p/21637/ Thu, 11 Mar 2021 23:10:41 -0500 I would agree that the execution phase is the most important or I would say critical part of the project but not necessarily because of the aspects you mentioned. I believe that Design Verification and Validation are the most important…   Read more»

]]> 8305a946ee55ccc01900d0b4ad696c7c https://medicaldevicecourses.com/activity/p/21636/ Thu, 11 Mar 2021 23:02:04 -0500 Every project manager is different in terms of how he wants to direct the project and guide his team. In my opinion below are the most important aspects of the execution phase: Setting priorities – The team has to focus…   Read more»

]]> 6ff37d1efed57960f9c6cf0401dd04dc https://medicaldevicecourses.com/activity/p/21511/ Wed, 03 Mar 2021 23:45:41 -0500 I love this class because it is more practical than anything I took before. It really highlights the real life situations that we are going to face in the industry, not just academic material that won’t be very valuable once…   Read more»

]]> d7ccca03747e49335448bd448d41d1e3 https://medicaldevicecourses.com/activity/p/21504/ Wed, 03 Mar 2021 02:13:19 -0500 In this week’s simulation, we are facing a failure of the growth factor with the carrier when being left in the syringe. There are numerous aspect to think about when it comes to failures like that, which can be caused…   Read more»

]]> 234075df863efc04241756e37f5ee4cd https://medicaldevicecourses.com/activity/p/21503/ Wed, 03 Mar 2021 01:59:55 -0500 The word “risk” itself tends to imply a negative result or red flag that the team should get away from. However, risk management is very beneficial to any project in order to evaluates all potential risks. Risk management file does…   Read more»

]]> 8b75bf92808bdba0642d45cd5b29951d https://medicaldevicecourses.com/activity/p/21438/ Wed, 24 Feb 2021 00:35:12 -0500 I think the most ideal solution in this case is to set up phase review meetings after each phase in order to review all documents and make sure that everything looks good with no mistakes that might delays things in…   Read more»

]]> 5eab1131d4a53da84ed48e08736119ed https://medicaldevicecourses.com/activity/p/21437/ Wed, 24 Feb 2021 00:29:32 -0500 In most companies, this should not be a problem. In the beginning of the project, it is much easier to face this issue than the end, since the due dates are more tight towards the end of the project. Usually…   Read more»

]]> b6969909f9ef45bc09a90c5fbf0bad74 https://medicaldevicecourses.com/activity/p/21436/ Wed, 24 Feb 2021 00:21:17 -0500 Setting timelines is very important to any project, since it determines the launch date of the product that is being developed or modified. Based on my experience, with the current technology most companies in the industries use excel to have…   Read more»

]]> 88cf6734d433aa081e11362bf544bc93 https://medicaldevicecourses.com/activity/p/21370/ Fri, 19 Feb 2021 00:33:28 -0500 Nowadays with COVID-19, this is a very common issue. Not getting a hold of someone is definitely possible since it is not that easy anymore to just stop by someone’s desk for 15min and get the answer to question. The…   Read more»

]]> 2b10b12e89f89096535760b664bf3cb7 https://medicaldevicecourses.com/activity/p/21369/ Fri, 19 Feb 2021 00:23:48 -0500 I agree that all phases are very important to ensure the success of the project and that often times the initiation or planning phases are argued to be the most important since a good foundation will ensure the success of…   Read more»

]]> 9e398b7c7c0535b700adf25e3e6c50f5 https://medicaldevicecourses.com/activity/p/21368/ Fri, 19 Feb 2021 00:13:09 -0500 Deciding on how long a task will take can be very tricky, but also very typical. Any project has a timeline and some milestones that have to get communicated to the business in order to decide on a launch or…   Read more»

]]> e960c918980aa9be7ec778f46c1e53e6 https://medicaldevicecourses.com/activity/p/21316/ Tue, 09 Feb 2021 01:03:24 -0500 Everything classified as a medical device would require a 510(k), unless they are exempt. Bandages are considered as class I medical devices used to cover and protect wounds, to hold together the skin edges of a wound, to support an…   Read more»

]]> c83fd2482b9cc6f622813772368d092c https://medicaldevicecourses.com/activity/p/21315/ Tue, 09 Feb 2021 00:46:45 -0500 With the technology getting better and better everyday, of course some products will decline by time and won’t have a need anymore, however, that does not mean that low volumes devices cannot be used anymore or are not needed. One…   Read more»

]]> a3a0660f770d39dce4a2c7a528878f19 https://medicaldevicecourses.com/activity/p/21314/ Tue, 09 Feb 2021 00:37:34 -0500 I wouldn’t think such issue or failure would require a recall. Recall is defined by the FDA as when when a medical device is defective, when it could be a risk to health, or when it is both defective and a…   Read more»

]]> 536af3e58d5747880088204a0c33d8e5 https://medicaldevicecourses.com/activity/p/21275/ Fri, 05 Feb 2021 01:19:21 -0500 So it really depends on the product. Most of the products functional testing are per ISO and ASTM standards, which are international standards that most of the international health authorities require. Sometimes there are extra standards to be followed besides…   Read more»

]]> a56663e3a5854b179c60380712d2f957 https://medicaldevicecourses.com/activity/p/21273/ Fri, 05 Feb 2021 01:05:21 -0500 Often times the business tries to push for new products or changes to existing products to be submitted to the FDA and cleared in order to meet the budget for that year or to meet a certain timeline that was…   Read more»

]]> 17980ec4c2852743581023e17b7ea52a https://medicaldevicecourses.com/activity/p/21272/ Fri, 05 Feb 2021 00:54:19 -0500 There is nothing guaranteed when it comes to design verification and validations, and especially when it comes to new product development. For sustaining projects, usually design verification should be very straight forward; since the product is already an existing product…   Read more»

]]> ed05bb938fc260740e87d07047ef2189 https://medicaldevicecourses.com/activity/p/21204/ Fri, 29 Jan 2021 02:04:31 -0500 Having the same regulations worldwide seems to be an easy solution to launch one product across all regions/countries without spending extra time trying to meet all those different regulations, however, it is not that easy of a solution. Every region/country…   Read more»

]]> 815c9c68012647fd7f8b26e0e25b3fba https://medicaldevicecourses.com/activity/p/21203/ Fri, 29 Jan 2021 01:48:29 -0500 I believe that there still can be an ideal PM. I feel like soft skills are the key for success of any project manager; problem solving, communication, and time organization are the most important soft skills that are a must…   Read more»

]]> 80afd707f7ec04e00848020748d4d7e2 https://medicaldevicecourses.com/activity/p/21202/ Fri, 29 Jan 2021 01:39:22 -0500 Even though engineering and design plays a huge role in coming up with a new project/product, the business need is far more important. Before presenting a project, a market research has to be done to determine the need of the…   Read more»

]]> 05ac0b6981f26d9f78de1a6dc7c91126 https://medicaldevicecourses.com/activity/p/21133/ Sat, 23 Jan 2021 19:23:48 -0500 Any project within the medical device industry requires some sort of design verification and validation work in order to ensure that the product is safe and effective. Timing can be very critical to the project since launching date is directly…   Read more»

]]> 275160a35c090ff4b9a0ff1053c9b962 https://medicaldevicecourses.com/activity/p/21132/ Sat, 23 Jan 2021 19:09:33 -0500 I agree, it is been really hard lately communicating things between team members due to the lack of face-to-face communication. Everything works best when you have the opportunity to just stop by someone’s desk and discuss something for 15min rather…   Read more»

]]> c8c9fa174613b41897eaf618bf157c2e https://medicaldevicecourses.com/activity/p/21131/ Sat, 23 Jan 2021 18:57:18 -0500 Repeated mistakes happen all the time due to associates leaving the company or moving to another position within the company without sharing their previous experience with the rest of their project team or function. Projects are never useless, even if…   Read more»

]]> da27e5b4b270489f0f46bfcbb4158783 https://medicaldevicecourses.com/activity/p/14350/ Wed, 15 May 2019 18:55:22 -0400 Strict policies are always a good routine to follow, to have a successful company so everything would run smoothly. I mean it is kind of understandable that you can only get a gift for the physician that is related to…   Read more»

]]> d8bf9a12503ceca3bee10cfa68ab2f61 https://medicaldevicecourses.com/activity/p/14349/ Wed, 15 May 2019 18:55:22 -0400 I wouldn’t trust or rely on any verbal agreement. no one should start any project based on verbal agreement, because if someone makes a promise verbally and breaks it, it is not considered a broken contract and that person cannot…   Read more»

]]> 169fb4ded0c17511f774527701cee79d https://medicaldevicecourses.com/activity/p/14348/ Wed, 15 May 2019 18:55:21 -0400 Dr. Simon, Thank you for such an amazing course. I’ve learned a lot from this course, especially because I’m majoring in Mechanical Engineering not Biomedical Engineering. The overall quality of this course is awesome, I got to know all the…   Read more»

]]> fe19182b7817512698432dc59e831291 https://medicaldevicecourses.com/activity/p/14215/ Wed, 15 May 2019 18:53:05 -0400 I think the matrix organization is the most efficient. The matrix organizational structure has a great influence on the project management. The matrix evolves to fill a need for an organization capable of dealing with great project size and complexity….   Read more»

]]> a8022a421badfd876c687b5e235211db https://medicaldevicecourses.com/activity/p/14214/ Wed, 15 May 2019 18:53:05 -0400 I work currently in a matrix organization, where employees have dual reporting relationships – generally to both a functional manager and a product manager. Project Managers may or may not have a lot of power. Functional Heads may or may…   Read more»

]]> 08368b794d828adbe603aaf8c008ddee https://medicaldevicecourses.com/activity/p/14213/ Wed, 15 May 2019 18:53:04 -0400 I think forming a project team is one of the hardest steps to take for the project to take place. Choosing the right people in the right department will help to make the project go smooth and be successful. It…   Read more»

]]> 9942e0cc38e53dd4f043551e5571b847 https://medicaldevicecourses.com/activity/p/14080/ Wed, 15 May 2019 18:51:43 -0400 Other risk management methods are: – Risk indicator scales: Works as a support for subjective judgement when the content and commercial environment of your project is routine and the scales have been calibrated. Often misused by inexperienced personnel who try…   Read more»

]]> 2b8bc641ccd75dea98fa01a36ef74f6b https://medicaldevicecourses.com/activity/p/14079/ Wed, 15 May 2019 18:51:42 -0400 The Risk assessment meeting is an important part of any project. The risk assessment meeting should be a formal meeting conducted during the project’s planning process. First step is the project manager has to send a meeting invitation to all…   Read more»

]]> 97b609a620c8abc9bfdf052837bc6f9a https://medicaldevicecourses.com/activity/p/14078/ Wed, 15 May 2019 18:51:42 -0400 Another risk factor to be considered for making decisions concerning product availability, compliance and enforcement is factors for the assessment of medical device benefits. Benefit, as described by the potential benefit factors, may change over time. FDA may assess the…   Read more»

]]> b46835a0929ac3a3c4975d91e524c6a6 https://medicaldevicecourses.com/activity/p/13950/ Wed, 15 May 2019 17:09:48 -0400 The verification protocol of every medical device or products has to consist of doing a test suitable for the desired purpose, then check the results. Based on the output of the test, it is decided if this product or device…   Read more»

]]> 7c326445429644b490a98d2db5628bfa https://medicaldevicecourses.com/activity/p/13949/ Wed, 15 May 2019 17:09:47 -0400 I think design verification is important, because in the initial stages of design verification is a key quality assurance technique. As the design effort progresses, verification activities become progressively more comprehensive. Verification is a theoretical exercise designed to make sure…   Read more»

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