https://medicaldevicecourses.com/members/shereenmurrah/activity/ Activity feed for shereenmurrah. Sat, 25 Apr 2026 00:06:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 1dbc9685d30685735fa72652de3eaaf8 https://medicaldevicecourses.com/activity/p/21050/ Sun, 29 Nov 2020 06:08:34 -0500 For a company, an expert or consultant helps reduce the chance of the device being rejected. They provide support for businesses since medical devices are heavily regulated and it’s a long process to have the device on the market. A…   Read more»

]]> 74886bdaf34a046f6684600e17111eee https://medicaldevicecourses.com/activity/p/21049/ Sun, 29 Nov 2020 05:58:24 -0500 The biggest difference between the two is that an oral agreement is harder to prove for its existence and must be proved by memory or other evidence since it is not written down. This can create error and mischief and…   Read more»

]]> 87b3f5c4065ce3a92afcdd704734f615 https://medicaldevicecourses.com/activity/p/21048/ Sun, 29 Nov 2020 05:44:37 -0500 Even though this is an awkward situation, it isn’t too restricting because this is a business dinner after all. Bringing a spouse to the business dinner is unnecessary, and if it does happen, then the physician should be in charge…   Read more»

]]> f68ecfac660e50ba231d09e86239b1fe https://medicaldevicecourses.com/activity/p/20982/ Sun, 22 Nov 2020 03:22:36 -0500 In my opinion, the best organizational structure is the functional structure Because: Employees are grouped by their knowledge in each area and this allows them to achieve high performance, having fixed roles and responsibilities which create less complications.There is only…   Read more»

]]> 4384acdc6bca07c4a2e6d2ebf272b36b https://medicaldevicecourses.com/activity/p/20981/ Sun, 22 Nov 2020 03:13:27 -0500 I would choose a functional organizational structure because the employees are grouped by their area of knowledge and there is one manager in charge. The project will have a team with knowledge in all areas and that way, it is…   Read more»

]]> 53e233bc80a0b5f615c2e05ca1c2ef62 https://medicaldevicecourses.com/activity/p/20980/ Sun, 22 Nov 2020 03:00:24 -0500 A successful project team should be goal oriented and the team members should have clearly defined roles. The team members should be open and clear when it comes to communication. A team should have balanced participation in order to have…   Read more»

]]> aa0be191059df9b9a9003aa1e0e6c2bc https://medicaldevicecourses.com/activity/p/20951/ Mon, 16 Nov 2020 04:38:44 -0500 I agree with the issues you listed above and there are many ways that risk management can go wrong. One of the ways could be reckless risk taking and it happens when the team is not taking sufficient risk oversight…   Read more»

]]> 82f4be5e857e3ea2cbb830f0a4efae29 https://medicaldevicecourses.com/activity/p/20950/ Mon, 16 Nov 2020 04:25:19 -0500 The risk management plan consists of scope, responsibilities/authority, review reqs and criteria, risk verification, data collection and review (production and post-production).  The first 3 clauses are introductory and requirement clauses. clause 4: intended use and foreseeable hazards, estimated risk for each hazardous situation clause 5: evalua…[Read more]

]]> bd8a6109308525c09b426ee2b4767052 https://medicaldevicecourses.com/activity/p/20949/ Mon, 16 Nov 2020 04:02:49 -0500 Other benefits of PMS is to monitor a device for its safety, quality and effectiveness throughout its entire lifetime. This gathers data about the device and helps in further research and prevention of certain risks in the future. This gives…   Read more»

]]> 7f5b385174fd1606264b01df6724073f https://medicaldevicecourses.com/activity/p/20876/ Mon, 09 Nov 2020 04:47:17 -0500 Verification is important for a few reasons: According to the FDA, “Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” So, Verification basically confirms whether the design outputs meet the design inputs. In order…   Read more»

]]> dc770e3b7cc09b206523f24e28796dd0 https://medicaldevicecourses.com/activity/p/20874/ Mon, 09 Nov 2020 04:39:51 -0500 Some ways to make validation pitfalls is to miss parts of the process, skip testing, excluding the packaging and labeling. To make Validation right, Your design validation process must include initial production units meaning to have the device built in…   Read more»

]]> 030c57f8fd1486558cafb51270c9ea37 https://medicaldevicecourses.com/activity/p/20870/ Mon, 09 Nov 2020 04:20:05 -0500 For trial periods, drugs are conducted in four phases (I,II,II and IV). The first three trials test for safety, effectiveness, dosage, and side effects, while phase IV is a continuation in testing after the FDA approves the drug. For devices,…   Read more»

]]> bd85ec775068f7da726f1a528db1fa57 https://medicaldevicecourses.com/activity/p/20800/ Mon, 02 Nov 2020 04:51:26 -0500 Disorganization and lack of planning and distributing of tasks can tear the design control system down. The nine steps of design control need to be implemented per code. When the process is not followed completely or specifically, it can cause…   Read more»

]]> fd201856b777aac592b2e6dab7bc700d https://medicaldevicecourses.com/activity/p/20799/ Mon, 02 Nov 2020 04:42:09 -0500 To make this simple, design control makes sure that there’s a plan set by the company or manufacturer that has to be implemented and makes sure all requirements are met during development. By doing so, design control protects patients from…   Read more»

]]> 241830036c48844e8daaba0aa8583c29 https://medicaldevicecourses.com/activity/p/20798/ Mon, 02 Nov 2020 04:33:22 -0500 Meeting minutes are crucial for assigning tasks and for each person to know what their task is if it is unclear. Also, meeting minutes give information on deadlines and what actions should be taken at each step of the way….   Read more»

]]> 2036fbccdf0deb6ffd3cc974a5ff5b2a https://medicaldevicecourses.com/activity/p/20703/ Sat, 24 Oct 2020 05:20:52 -0400 Having a clinical background isn’t necessary as long as the role doesn’t deal with direct patient interaction. So depending on the role that the person is going for, the preference of a clinical background should then be determined. Having a…   Read more»

]]> d4311898dfdea2c17f93b4e61ef1262b https://medicaldevicecourses.com/activity/p/20702/ Sat, 24 Oct 2020 05:05:07 -0400 If a company invests in developing a new drug/device, then they should follow all the regulations to have an effective product. Clinical trials aid in the success of every drug or device in the market. Anything that humans will use…   Read more»

]]> feaf00641ccea7070078a6bb696d05f8 https://medicaldevicecourses.com/activity/p/20701/ Sat, 24 Oct 2020 04:34:27 -0400 The FDA requires that any device or drug made and will be used to treat humans, should go through a clinical study/trials. Even if these drugs or devices do not improve the overall wellbeing of humans, we still need them…   Read more»

]]> 2798b4daeff8ff6074774bb819454486 https://medicaldevicecourses.com/activity/p/20635/ Sat, 17 Oct 2020 03:35:01 -0400 I have noticed that technological companies use the color blue such as Samsung, Dell, Intel, HP, ATT, and GE. Also, car manufacturers such as Ford, Volkswagen, Subaru, BMW, Volvo and many others incorporated blue in their logos to represent Strength,…   Read more»

]]> 1b6aac0d725c48556d344389885647d0 https://medicaldevicecourses.com/activity/p/20634/ Sat, 17 Oct 2020 03:05:16 -0400 Coca-Cola will always be one of my favorite commercials because it just makes me crave it every single time. The way they make it look and sound refreshing just makes it impossible to resist. But my most favorite of all…   Read more»

]]> ca593abb906dba02d97d56599e4c7364 https://medicaldevicecourses.com/activity/p/20633/ Sat, 17 Oct 2020 02:37:28 -0400 People spend most of their time on social media every single day that it’s become a habit. The use of television has vastly decreased due to the rise of social media. When using my phone to search for products online,…   Read more»

]]> 1db05671651a39b2e0d5f2541cf019ce https://medicaldevicecourses.com/activity/p/20574/ Fri, 09 Oct 2020 03:59:29 -0400 I would want to be part of an LLC if I would to start my own business. I chose it over Sole and partnership because I would want my business to continue even after I’m gone, and have my kids…   Read more»

]]> c24794f6245d2b4cc1e5e690ed4b85d3 https://medicaldevicecourses.com/activity/p/20572/ Fri, 09 Oct 2020 03:43:38 -0400 When starting a business, it is important to choose the right corporation that fits your needs as well as your family’s needs. Some people choose sole proprietorship because it is the easier option and there are less risks associated with…   Read more»

]]> 3ae34e423b2282e0eea8552f5ed9ea98 https://medicaldevicecourses.com/activity/p/20571/ Fri, 09 Oct 2020 03:31:24 -0400 If I were to choose between the two, I would go with partnership. The advantages and disadvantages in both are very similar, but having a partner to run the business with you is of a great help. The responsibilities can…   Read more»

]]> efcb4bd1c323600d325624b9fd303464 https://medicaldevicecourses.com/activity/p/20521/ Sat, 03 Oct 2020 02:32:26 -0400 Companies fail to adhere to the regulations set by the FDA even with this form because maybe it takes longer time than usual to improve these mistakes. It might not be intentional for these companies to keep breaking the rules,…   Read more»

]]> 933deab568267bb93eaade5d666f4612 https://medicaldevicecourses.com/activity/p/20520/ Sat, 03 Oct 2020 02:18:04 -0400 Companies can have a department associated with researching the latest relatable technologies and to keep track of emerging future technologies. Proper research can help the company decide whether a certain technology is needed or not, and what are the risks…   Read more»

]]> 5c8265187c918b223fbe9f4b0847a280 https://medicaldevicecourses.com/activity/p/20519/ Sat, 03 Oct 2020 02:04:19 -0400 The Quality Control department in any company needs commitment in the workplace by employees. The company needs to make sure that everyone is on the same level of understanding what the mission is for the company, and how the employees…   Read more»

]]> c0f92b3ccb2ea59501f12eb37273b965 https://medicaldevicecourses.com/activity/p/20484/ Mon, 28 Sep 2020 03:59:12 -0400 Combination Product: Promus Element Stent  This stent is coated with a drug that helps reduce the chances of arteries becoming blocked. The stent is designed to fit in the arteries and prevents blockage. I believe it falls under the Center…   Read more»

]]> 41d401f40b1bc353ce26fac1d057364e https://medicaldevicecourses.com/activity/p/20483/ Mon, 28 Sep 2020 03:39:32 -0400 Regulations in other countries are not as strict as the USA. It is much easier to get drugs approved that are not safe and have no benefit either. A drug that is banned in the USA but is available in…   Read more»

]]> 43597ada3978a4b8602872d90c22e69e https://medicaldevicecourses.com/activity/p/20476/ Mon, 28 Sep 2020 03:17:27 -0400 It could take up to 14 years or more in order to develop a new drug and have it approved by the FDA. While this may be an extremely long process, it is necessary to avoid having companies take advantage…   Read more»

]]> a5b1dea8acf5cb7b04a61e936f877840 https://medicaldevicecourses.com/activity/p/20396/ Mon, 21 Sep 2020 00:31:03 -0400 There is a lot of rules and pressure that comes with choosing one biomaterial over another. A Project manager should consider many aspects while choosing the right biomaterial for the specific case. A human body is very complex, so introducing…   Read more»

]]> ad48d68158e7907ebe3c4638adca695c https://medicaldevicecourses.com/activity/p/20393/ Mon, 21 Sep 2020 00:08:07 -0400 Both research types take a very long time before seeing any results, or before using the results to make changes. But, I agree with research done in industry is faster and if lucky, we might see the products developed in…   Read more»

]]> 81c2aa8d963b794a54a4ab33636a25d8 https://medicaldevicecourses.com/activity/p/20392/ Sun, 20 Sep 2020 23:39:15 -0400 Although it may be hard to eliminate animal testing, technology is evolving and scientists need to find alternatives to animal testing. Animal testing is a cruel method to make studies and develop drugs/devices. Animal testing should not be allowed unless…   Read more»

]]> 59cd26a3b16f0b475005465e8116ae46 https://medicaldevicecourses.com/activity/p/20329/ Wed, 16 Sep 2020 03:17:56 -0400 Practical experience in our rapidly growing industry is necessary. Students begin searching for career related jobs either while studying or right after graduating. Companies nowadays give graduates a hard time with their requirements to start working. Some companies require some…   Read more»

]]> 76e46cca9039aac151f57b79ecf064c3 https://medicaldevicecourses.com/activity/p/20328/ Wed, 16 Sep 2020 03:17:56 -0400 Without both Academia and industry professions, our world wouldn’t be where it is now. Even though many people prefer industry over academia, I believe that money shouldn’t be the drive to choose between the two. Academia gives people the chance…   Read more»

]]> 3b8bb31448a23e83aac4800dddd678c6 https://medicaldevicecourses.com/activity/p/20327/ Wed, 16 Sep 2020 03:17:55 -0400 A BS degree in BME should help students initially in starting out with an entry level position. Most companies actually require that a student has a BS degree. With a BS degree and an entry level job, students can make…   Read more»

]]> 7bf74a1f79695afc08e6b7fb79cfeef2 https://medicaldevicecourses.com/activity/p/20326/ Wed, 16 Sep 2020 03:17:55 -0400 For the success of every project, it is crucial to implement all the phases according to plan. Although, I can assume that the initiating phase carries the most importance into running a successful project. The hardest decision in anything we…   Read more»

]]> 956cc1aef511b31ddf940b86ca599ff8 https://medicaldevicecourses.com/activity/p/20325/ Wed, 16 Sep 2020 03:17:54 -0400 One question that I would ask myself is: what are the risks that are associated with my project from phase A-Z? knowing your risks is crucial especially if the investments you’ve made are not enough to cover for plans B,…   Read more»

]]> 8a7d9d5e247f34bc114d827fa015ca72 https://medicaldevicecourses.com/activity/p/20324/ Wed, 16 Sep 2020 03:17:54 -0400 Having more than one manager per project is helpful if each manager specializes in something. Some issues occur that require more than one manager to help or solve the problem. For instance, a manager who specializes in technical issues can…   Read more»

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