https://medicaldevicecourses.com/members/sfrancis/activity/ Activity feed for sfrancis. Sat, 16 May 2026 12:04:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8047d5ae392e9a458d6e444606f5ae35 https://medicaldevicecourses.com/activity/p/23662/ Sun, 10 Oct 2021 02:06:32 -0400 Post-market surveillance serves an important purpose. Even though medical devices go through rigorous testing pre-market, some adverse events could pass through this phase unnoticed. Post-market surveillance allows for the monitoring of medical devices after they have hit the market. There…   Read more»

]]> 1a511e90c3165381f957c953c4bb4804 https://medicaldevicecourses.com/activity/p/23661/ Sun, 10 Oct 2021 02:00:05 -0400 A set record of files and documents that are produced by risk management  comprises the risk management file. It should consist of risk evaluation, risk control measures, risk estimation, the risk management plan, and the criteria for risk acceptability among…   Read more»

]]> b3a064bb41c9ae3f098d63fedbc50468 https://medicaldevicecourses.com/activity/p/23660/ Sun, 10 Oct 2021 01:48:58 -0400 Implementing risk management is not only ethical but also it provides context on whether a company should purse a project. The risk management process runs throughout the product life cycle starting in pre-market where experimentation begins, running throughout the product…   Read more»

]]> 3376beec1ccbd074b1c27b2ef187e74d https://medicaldevicecourses.com/activity/p/23554/ Sat, 02 Oct 2021 21:08:59 -0400 Meeting minutes serve as an official record of the proceedings that took place. Not only does it keep people in the loop that missed the meeting, but also it also serves as a place of reference when needed. On would…   Read more»

]]> b8c09da32607884b546d7f7d38fe1a0a https://medicaldevicecourses.com/activity/p/23553/ Sat, 02 Oct 2021 20:21:04 -0400 Design controls are a necessary procedure of medical device development. According to the FDA, 44% of voluntary recalls from October 1983 to September 1989 could have been prevented by adequate design controls and the most frequent causes for recalls are…   Read more»

]]> 21e1792a8764fdfc161a2a44a406d11f https://medicaldevicecourses.com/activity/p/23552/ Sat, 02 Oct 2021 20:11:41 -0400 Proper design controls are needed due to the most frequent causes of recalls being from issues related to design. Design controls are a set of qualities and procedures set forth by the FDA to ensure the medical device meets user…   Read more»

]]> 94c2bd8d461e1c0e948d64bdd68d8a89 https://medicaldevicecourses.com/activity/p/23455/ Sat, 25 Sep 2021 02:21:35 -0400 The Right to Try Act gives hope to individuals who have terminally ill diseases. Trying these medications that are in early phases of development is very risky. If some of these medications are successful, I think this is a great…   Read more»

]]> e8aee183ce12069312d0c60171c4090f https://medicaldevicecourses.com/activity/p/23454/ Sat, 25 Sep 2021 02:12:34 -0400 Double blind studies provide an extra veil to protect the integrity of the study. Having both the participants and the medical professionals blind to who is receiving which treatment. This yields any unintentional biases that the medical professionals could unknowingly…   Read more»

]]> 796ff11534a8c9fee56aac0569476d0e https://medicaldevicecourses.com/activity/p/23452/ Sat, 25 Sep 2021 02:01:29 -0400 A placebo-controlled trial occurs when one group of study participants receives the active treatment, while the other group of study participants receives a placebo. Everything else is held the same between the two groups, so that any difference in their…   Read more»

]]> dc603ed8d7d2ebb6f4760b7887b4a851 https://medicaldevicecourses.com/activity/p/23388/ Sun, 19 Sep 2021 02:56:30 -0400 I think looking into a company’s corporate structure before accepting the job is a good idea. Before this course, I would not have thought to do so and instead just focused on the mission statement and the company’s vision.  However,…   Read more»

]]> 23fddba0154f0a96aa10aac5bfdaaf54 https://medicaldevicecourses.com/activity/p/23386/ Sun, 19 Sep 2021 02:45:27 -0400 A public company issues publicly traded stock, can have unlimited shareholders, is responsible to the SEC, must report financial data quarterly, is subject to Sarbanes-Oxley and PCAOB, can give employees stock options among other rewards. Some examples of a public…   Read more»

]]> e0012b465b88e53a4df6c25dfe3f9229 https://medicaldevicecourses.com/activity/p/23383/ Sun, 19 Sep 2021 02:27:44 -0400 Establishing a partnership with a business partner can have many advantages; owners having complete control, keeping all the profits, splitting the profits by ownership percentage, few legal restrictions and, uncomplicated taxes are a few. However, there are many disadvantages when…   Read more»

]]> d1521f61bbf73faf882e50285c874f13 https://medicaldevicecourses.com/activity/p/23280/ Sun, 12 Sep 2021 01:12:58 -0400 A document control system ensures a company is following the proper document management and manufacturing practices required for quality and regulatory compliance. It can also help reduce regulatory risk. To improve a document control system is by introducing automation to…   Read more»

]]> afcf992a3af7bbd4cb5cc42f48f36c81 https://medicaldevicecourses.com/activity/p/23277/ Sun, 12 Sep 2021 00:40:21 -0400 Precision and accuracy are very important measurements in science especially when dealing with medical devices and quality control systems. These two measurements have a direct impact on patient health. The FDA requires that medical devices should be precise producing the…   Read more»

]]> f7d0e22ecd345e63992cc509f1b02bba https://medicaldevicecourses.com/activity/p/23275/ Sun, 12 Sep 2021 00:24:50 -0400 This is a really great question. I do not think that the FDA’s rules and regulations are too strict. Even though their mission statement is two prong wanting to ensure patient safety while advocating for innovation, the rules and regulations…   Read more»

]]> 30a05d8176a1e663a8dd54468943646f https://medicaldevicecourses.com/activity/p/23152/ Sat, 04 Sep 2021 16:01:43 -0400 Animal research is essential to understanding the pathology and treatment of diseases. I can understand why some animal activist groups deem animal research to be flawed and unethical, but there is not another model that can mimic human disease as…   Read more»

]]> b6c7789d5a6a5104734c8135aa7dfb99 https://medicaldevicecourses.com/activity/p/23151/ Sat, 04 Sep 2021 15:28:50 -0400 The academic sector is research and discovery focused with many of the projects focused on expanding the current knowledge scope of the field. While industry relies on creating products that can have an immediate impact on lives while making a…   Read more»

]]> 4af6a4212b2228c5e81e8838201e2cca https://medicaldevicecourses.com/activity/p/23110/ Thu, 02 Sep 2021 00:40:43 -0400 In academia, research is pursued based on passion leading to a thrill of discovery. Thought leaders in this field have success paths that follow the ways of earning a Nobel Prize, becoming Head of the Department, fame, notoriety, being an…   Read more»

]]> 85a5d3ffdb5ea7c653aeea346751932b https://medicaldevicecourses.com/activity/p/23086/ Sat, 28 Aug 2021 19:55:44 -0400 When pursuing new roles, I prefer to be under qualified for the position, this would allow for growth by learning new ideologies and concepts on the job while also providing a challenge. Being overqualified for a position does not provide…   Read more»

]]> 980c4f1fbb82f85fc509830a6a1a0a15 https://medicaldevicecourses.com/activity/p/23085/ Sat, 28 Aug 2021 19:38:25 -0400 Even though medical devices are used across a variety of fields, I do not think it would be beneficial for individuals to pursue a medical device certificate if they do not intend to work in the field. Although gaining knowledge…   Read more»

]]> b618a8e9590344c19e989b4e2363e946 https://medicaldevicecourses.com/activity/p/23083/ Sat, 28 Aug 2021 19:25:17 -0400 Consulting can be a very rewarding career field, allowing for problem solving to achieve a desired result. According to Harvard Business School, there are eight fundamental principles of consulting; providing information to a client, solving a client’s problems, making a…   Read more»

]]> 2b2f10367dfbc7be39eb1dee9ae8377e https://medicaldevicecourses.com/activity/p/22998/ Fri, 20 Aug 2021 16:18:39 -0400 There should be systems in place to mediate the risk of having a valuable employee leave during the middle of the project. There should be other personnel who are also equipped to do the job. During their last two weeks…   Read more»

]]> 34965ae0c01b7e04b0adcb6529855516 https://medicaldevicecourses.com/activity/p/22997/ Fri, 20 Aug 2021 16:03:14 -0400 Human resources should play a significant role at all companies. The purpose of HR is to recruit, hire, and train employees but I think within well established companies there purpose goes well beyond just those three initiatives. HR should also…   Read more»

]]> f7e7d54ead1610c9a74c0276491a0dca https://medicaldevicecourses.com/activity/p/22993/ Thu, 19 Aug 2021 01:15:49 -0400 Although both aspects of quality management, quality assurance and quality control are two discrete concepts. Quality assurance is process oriented and focuses on preventing quality issues while quality control is product oriented and focuses on identifying quality issues in manufactured…   Read more»

]]> 699f391d81e082216d46eaf5d76ab133 https://medicaldevicecourses.com/activity/p/22972/ Fri, 06 Aug 2021 22:45:36 -0400 As a project manager, it is important to know how to deal with interruptions in project schedules which could very well be caused by employee vacation times or other obligations that need tending to. Therefore, developing systems to seamlessly transition…   Read more»

]]> c39d17f57324fcae6b0753cfcf37d192 https://medicaldevicecourses.com/activity/p/22971/ Fri, 06 Aug 2021 22:45:18 -0400 When an employee leaves a company, there is always some sort of disruption, minimizing this disruption is key to keeping the project on tack. Ideally, the project manager will put in notice of their departure early enough so that there…   Read more»

]]> 3ca95d41ee93dd411fb6fd308fc0da6d https://medicaldevicecourses.com/activity/p/22970/ Fri, 06 Aug 2021 22:44:54 -0400 Some reasons that could increase the cost of a project are poor budget estimates, scope creep, and even inflation could be a factor. Before executing a project, the budget should be carefully planned out with an accompanying risk management plan…   Read more»

]]> 4be7423aeeb5279a8544b337bd6f59f9 https://medicaldevicecourses.com/activity/p/22955/ Fri, 30 Jul 2021 21:01:13 -0400 Although a crucial skill in project management, calculating task duration can be difficult for new project managers or new projects in general. Time duration can serve as a metric of whether a project has succeeded or failed depending on whether…   Read more»

]]> f60c1c4973368fc4ec4b199a27990d9b https://medicaldevicecourses.com/activity/p/22954/ Fri, 30 Jul 2021 21:00:27 -0400 I have learned so much in this project management course. Before this course, project management was such a broad undefined term in my vocabulary. Now, I am clear on the definition of project management and how to apply these principles….   Read more»

]]> ccd3d4392e94fc821eff609636031d51 https://medicaldevicecourses.com/activity/p/22948/ Thu, 29 Jul 2021 00:14:39 -0400 As a project manager there will always be team problems and issues. Having effective management skills will keep problems and issues to a minimum. Developing systems to seamlessly transition job duties when employees are on vacation, quit, or take a…   Read more»

]]> 18aa2b251e967a4af991243dcd097422 https://medicaldevicecourses.com/activity/p/22939/ Fri, 23 Jul 2021 21:05:17 -0400 There are many factors that contribute to the success of a project. The five factors mentioned above consisting of agreeing on project goals, effective communication, developing clearly defined plans with assigned responsibilities, managing project scope, and making sure of management…   Read more»

]]> b6094ab23648a82220399445a4d6eb37 https://medicaldevicecourses.com/activity/p/22938/ Fri, 23 Jul 2021 21:04:37 -0400 Keeping detailed accounts of work completed and how it is completed is important for the continuity of projects, in addition to holding extreme value in the monitoring, controlling, and closure phases of a project. Detailed record keeping should be done…   Read more»

]]> fd853f307435f252e0567aa355b6bb8c https://medicaldevicecourses.com/activity/p/22934/ Thu, 22 Jul 2021 00:46:08 -0400 There can be many reasons as to why a project can fail ranging from unclear goals, shifting goals, lack of communication, poorly defined project scope, lack of risk management, lack of follow up, and poor timing.  All of the aforementioned…   Read more»

]]> 8f51946506fedb6c1bab56305701fcdd https://medicaldevicecourses.com/activity/p/22921/ Fri, 16 Jul 2021 22:56:58 -0400 Validation and verification are two independent procedures used in conjunction to check that a product, service, or system meets the requirements and specifications for its intended purpose and assures that it meets the needs of the customer and other identified…   Read more»

]]> 62bc582056308803567dc7c7ece5f735 https://medicaldevicecourses.com/activity/p/22919/ Thu, 15 Jul 2021 01:19:13 -0400 Great question. I think the best project managers have a mix of both higher education and valuable work experience. There are some qualities of a good project manager, including creativity and growth, that can only be learned on the job…   Read more»

]]> aa1632709094a4005a7d11c25fe3f807 https://medicaldevicecourses.com/activity/p/22918/ Thu, 15 Jul 2021 00:38:49 -0400 Keen organizational skills are necessary on any level of the career ladder. This allows for increased multitasking enabling individuals to efficiently perform essential job tasks while eliminating ineffective management systems. A well-organized project manager displays a sense of reliability and…   Read more»

]]> 1745e3977b81756bda765c0807a31f82 https://medicaldevicecourses.com/activity/p/22903/ Sat, 10 Jul 2021 23:31:53 -0400 Although it is important for project managers to possess many competencies, the three core competencies I think are most important for a project manager to possess are effective team building skills, delegation skills, and problem solving skills. Through team building,…   Read more»

]]> 80f3a8df1237db69b3c0a94709fcb92f https://medicaldevicecourses.com/activity/p/22902/ Sat, 10 Jul 2021 23:01:44 -0400 There are many advantages of grouping projects under a program. First, it will allow for those projects to share the same resources like employees and budgets to ensure that they are used in the most effective way saving time and…   Read more»

]]> 97799bd5f3769d485793ffe1c6aee4be https://medicaldevicecourses.com/activity/p/22893/ Thu, 08 Jul 2021 01:14:30 -0400 I find that I prefer the supportive project management style. A leader should be approachable and show value and respect to their subordinates while inadvertently projecting a more directive managing style. With this combination, it allows for a more collaborative…   Read more»

]]> 8e565286d0de82748852381a16e10005 https://medicaldevicecourses.com/activity/p/22871/ Sun, 04 Jul 2021 01:21:22 -0400 One of the most important undertakings of a project manager is securing the right team members. This could be a difficult task because a candidate with the most experience and the preferred educational background may not possess the emotional intelligence…   Read more»

]]> 3bcee9e2818c8bf5fb1d5bdaa12c9abe https://medicaldevicecourses.com/activity/p/22870/ Sun, 04 Jul 2021 01:07:34 -0400 Emotional intelligence is defined as the ability to perceive, use, understand and manage emotions. As a project manager, having this ability will not only allow for enhanced communication among your team but will also allow for project managers to deal…   Read more»

]]> a23bf04a969b246ac66160fdd8867783 https://medicaldevicecourses.com/activity/p/22859/ Thu, 01 Jul 2021 03:26:32 -0400 Communication is a vital part of the project phases. Having great communication with your team is a must for those in leadership and sets the tone for the rest of the project. Before starting a project time management and organizational…   Read more»

]]> d4b39531b87e2a39d2352e6e5256e479 https://medicaldevicecourses.com/activity/p/22835/ Wed, 30 Jun 2021 03:29:01 -0400 0