https://medicaldevicecourses.com/members/ala26/activity/ Activity feed for ala26. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b39be85afd3a7c59d7dc24fa6242303b https://medicaldevicecourses.com/activity/p/17377/ Wed, 15 May 2019 21:38:58 -0400 One thing I really enjoyed about the course is that we got to explore so many of the other positions available in industry. I have only been in the industry for a year or so and did not realize how…   Read more»

]]> 9210c243b8fe318117e6cfc6f3840d86 https://medicaldevicecourses.com/activity/p/17375/ Wed, 15 May 2019 21:38:57 -0400 A patent is a piece of paper that allows one to have ownership of an idea or invention. NDA is known as a non-disclosure agreement. It’s an agreement in which people or companies agree to keep information confidential. So basically…   Read more»

]]> 0f6420c2c7ac5eb7ea8054bb8b21e0ac https://medicaldevicecourses.com/activity/p/17374/ Wed, 15 May 2019 21:38:57 -0400 In any situation I believe that a written contract is necessary. The difficulty in proving an oral contract is that you must rely on the memory of the parties and other evidence. Depending on the memories of people allows one…   Read more»

]]> 3ea70180f0eedadfb1053f93b3eadb1f https://medicaldevicecourses.com/activity/p/17249/ Wed, 15 May 2019 21:37:56 -0400 If I am to form a project team, I would choose people who have the qualification and experience over people who I know get along with each other. From my work experience so far, people who do not really get…   Read more»

]]> f62e2daa738d7be23fd6e6164021adaa https://medicaldevicecourses.com/activity/p/17248/ Wed, 15 May 2019 21:37:56 -0400 I believe that in order to be prepared for upper management, you need middle management experience. Middle management works with both upper management and lower levels of the company. As you mentioned, middle management works to fulfill the vision of…   Read more»

]]> 615b826a3ed0bc4e93f03641bd751bcb https://medicaldevicecourses.com/activity/p/17247/ Wed, 15 May 2019 21:37:55 -0400 My team had their first meeting last Saturday. During this meeting we discussed everyones role and what documentation is necessary from each department. We discussed which documents should be completed as soon as possible because it is needed from other…   Read more»

]]> 7018fe2344e2ca1729ae23306646d5ff https://medicaldevicecourses.com/activity/p/17171/ Wed, 15 May 2019 21:37:14 -0400 Risk-benefit factors for assessment of medical device risk includes:
1) Severity of harm
2) Likelihood of risk
3) distribution of nonconforming devices
4) duration of exposure to population
5) False-positive or false-negative results
6) tolerance of risk
7) risk factors for healthcare professionals and caregivers

]]> 661a604564d82cdd2597f495866b4d85 https://medicaldevicecourses.com/activity/p/17170/ Wed, 15 May 2019 21:37:14 -0400 A few points for risk management: 1) ISO 14971, this standard is accepted throughout the world 2)FMEA is not risk management 3) establish a risk management policy and procedure 4)keep severity, probability, and risk levels simple 45use risk management as…   Read more»

]]> 8f1926286563547e585f4e17af09d922 https://medicaldevicecourses.com/activity/p/17169/ Wed, 15 May 2019 21:37:13 -0400 I read another article on risk management and it mentions other errors: 1) Lack of integration: silos between risk management and development 2) Understand and incorporate “intended use” in your risk management process 3) Failing to conduct and document risk-related…   Read more»

]]> 4cfab5c66e3509581d6a4a9fcee63305 https://medicaldevicecourses.com/activity/p/17061/ Wed, 15 May 2019 21:36:20 -0400 A validation is defined as conformation by examination that the particular requirements for a specific intended use can be fulfilled. Examples of when validations is required are sterile package sealing processes. An example of when a validation is not required…   Read more»

]]> f0956283ff54238be54f758aeb6a120f https://medicaldevicecourses.com/activity/p/17060/ Wed, 15 May 2019 21:36:19 -0400 There are a lot of things that can go wrong when you have insufficient design controls. The obvious outcome would be a decrease in quality which can put your costumers in danger. Sometimes when the design control is too detailed,…   Read more»

]]> cb7dbb1a2e006c5bde9323964d99efa8 https://medicaldevicecourses.com/activity/p/17059/ Wed, 15 May 2019 21:36:19 -0400 I recently finished an internship with a medical device company and two of my projects involved drafting a validation. I have a few advices to successfully complete a validation. 1. Try to draft it asap and e-mail all the people…   Read more»

]]> 270cddac76169f95dd7cf52e6df5a730 https://medicaldevicecourses.com/activity/p/16966/ Wed, 15 May 2019 21:35:31 -0400 One of the task I had to work on as an intern was validation. The first step for a successful validation is that everyone on the team does their part in a timely manner. For example, the team ensures the…   Read more»

]]> 7f90fdc016807c70450c020fcc5e8cfb https://medicaldevicecourses.com/activity/p/16965/ Wed, 15 May 2019 21:35:31 -0400 Minutes for meetings has been very important and useful to me in the medical device industry. For example, I had to take minutes for a quarterly quality meeting that we had. In the meeting we discussed some important points that…   Read more»

]]> 1ccce06b1888aa17cd6b5d0e032457df https://medicaldevicecourses.com/activity/p/16964/ Wed, 15 May 2019 21:35:30 -0400 I had to draft up the validation and protocol for two machines a few months ago. The plan used is known as Acceptable Quality Limit (AQL). It is a …”statistical method that is used to test the quality level that…   Read more»

]]> b42223a2f8400949a228d1a9ba48e980 https://medicaldevicecourses.com/activity/p/16882/ Wed, 15 May 2019 21:34:48 -0400 If I was involved in clinical research, I would want to be a clinical research coordinator. A clinical research coordinator’s job is to make sure everyone in the team is complying with all the rules and regulations. They also work…   Read more»

]]> 63309ac5ca831217e6aea151dc45a0db https://medicaldevicecourses.com/activity/p/16881/ Wed, 15 May 2019 21:34:47 -0400 I believe placebo-controlled trials are very necessary. There is something known as the placebo effect which is when a placebo drug or treatment is not due to the actual drug/treatment but due to the patient’s belief. If patients knows what…   Read more»

]]> c5e5cc9c5ea80e8bb26bd593448cc4f1 https://medicaldevicecourses.com/activity/p/16880/ Wed, 15 May 2019 21:34:47 -0400 If the job is more desk work related such as a statistician, bioinformatics, ect, a clinical background is not required. I believe a clinical background is necessary if you are are going to directly deal with patients.A principle investigator and…   Read more»

]]> 06d9b5aaa4822271f42661c670bde556 https://medicaldevicecourses.com/activity/p/16771/ Wed, 15 May 2019 19:42:27 -0400 The color of brands is extremely important in marketing and brand design. It is stated that, “…90% of snap judgements are made based solely on color.” In healthcare, the leading color used by brands is blue. Blue is associated with…   Read more»

]]> b691bc6fe1a4624089fdeb227a150198 https://medicaldevicecourses.com/activity/p/16769/ Wed, 15 May 2019 19:42:26 -0400 Marketing is when you get costumers and potential buyers interested in your company’s service or product.E Jerome McCarthy came up with 4 P’s of marketing: 1. Product: Some questions asked are who is the target for this product? Is the…   Read more»

]]> d375604fa08be1c900f8f431b8b2841f https://medicaldevicecourses.com/activity/p/16768/ Wed, 15 May 2019 19:42:25 -0400 A company I recently worked for is known as Zimmer Biomet, an orthopedic medical device company. Mission statement: Lead the industry in delivering value to healthcare providers, patients and stockholders, while embracing our broader social responsibility. Vision Statement/purpose: Restore mobility,…   Read more»

]]> 14b8ad499a85b898c1c1d804021a0eaf https://medicaldevicecourses.com/activity/p/16615/ Wed, 15 May 2019 19:40:51 -0400 I recently read an article in WallStreetMojo with discusses the top differences between a private and public company. As mentioned several times above, a public company is able to sell their shares to the public (millions and millions of shareholders)….   Read more»

]]> cebdbd0b152fa4f4b623c974d57ff018 https://medicaldevicecourses.com/activity/p/16613/ Wed, 15 May 2019 19:40:50 -0400 I believe a company’s type as well as their financial standings throughout the years is something to consider when deciding to work with them. I think this is extremely important when you have been working in the field for a…   Read more»

]]> 2b0b3b720e9dcf2c859360b5fabccade https://medicaldevicecourses.com/activity/p/16611/ Wed, 15 May 2019 19:40:49 -0400 I researched the company Prudential Financial , Inc (2017) Revenue: $59, 289 Return on Average equity: 16.0% Operating Return on average equity: 13.0% Benefits and expenses: 53, 202 Net Income (Loss): $7,974 Financial position: Invested assest: $469, 871 Total assets:…   Read more»

]]> 445cf5370176b044d3a31464a8d9f3b4 https://medicaldevicecourses.com/activity/p/16542/ Wed, 15 May 2019 19:40:10 -0400 I worked as a QA co-op and experienced the conflict between QA and another department. The conflict I experienced was the QA department with the manufacturing department.QA is very by the book and ensure that all the procedures as well…   Read more»

]]> 7e184c2cb9ced4946bd42e8b8eee7428 https://medicaldevicecourses.com/activity/p/16540/ Wed, 15 May 2019 19:40:08 -0400 I worked as a QA co-op and recently finished in the summer. My day to day task varied depending on if any issues came up with machines or parts. On an average day, I would work on document updates and…   Read more»

]]> a80becaba65eabc567a54edeb93e4323 https://medicaldevicecourses.com/activity/p/16538/ Wed, 15 May 2019 19:40:07 -0400 I worked as a quality intern and participated in a BSI audit over the summer. The first thing we went through were gaps in our current documents and work instructions. If we found any gaps we would issue a CAPA…   Read more»

]]> 33bc39b687e4f36981baf7ada6c69e6f https://medicaldevicecourses.com/activity/p/16442/ Wed, 15 May 2019 19:39:20 -0400 I recently read an article that was published in 2015, that discussed if the FDA was being to strict and the consequences from it. The article argues that the FDA is strict because there are more severe consequences from approving…   Read more»

]]> 0b823c332a71936d2b0c83fda71cabaf https://medicaldevicecourses.com/activity/p/16440/ Wed, 15 May 2019 19:39:19 -0400 I recently just finished my internship in August and had the opportunity to work with many people from different backgrounds. In terms of their physical looks, it has never impacted my work. Each person had their own drives and ideas…   Read more»

]]> 563d7d984e36ca201fd2a688fc7bff8e https://medicaldevicecourses.com/activity/p/16437/ Wed, 15 May 2019 19:39:17 -0400 I do not think e-cigs should be classified as a class III medical device due to the lack of studies regarding it’s safety. Also, class III devices are classified as devices that have a high risk to the user. I…   Read more»

]]> 10350f73d39eb408101b28a3d0cfa318 https://medicaldevicecourses.com/activity/p/16347/ Wed, 15 May 2019 19:38:23 -0400 Research in academia versus industry differ in many ways. The first is that industry research is usually aligned with what is high in demand in the market or it must be aligned with the goals of the company. It usually…   Read more»

]]> 1fe474bce79184cf6d1efa8eb530a622 https://medicaldevicecourses.com/activity/p/16346/ Wed, 15 May 2019 19:38:22 -0400 I personally am interested in research that would be beneficial in the present. I agree that most researchers probably do not go into this with a set timeline such as if it is for the present or future. I do…   Read more»

]]> daff5f2b420b0b25557084a737df94f5 https://medicaldevicecourses.com/activity/p/16345/ Wed, 15 May 2019 19:38:22 -0400 I understand where groups such as PETA believe testing animals for research is unethical since there are some cases where the animal may suffer. I do believe though it is more unethical to do research testing on humans first. As…   Read more»

]]> 041854196150af73d1b5f83aa5751849 https://medicaldevicecourses.com/activity/p/16253/ Wed, 15 May 2019 19:37:28 -0400 I worked under two different project managers in the past year. The first project manager I worked for was very assertive and wanted the work done earlier than the deadline. She would constantly check my work and give me feedback….   Read more»

]]> 3f010a9a71d0c463f8bba4579a7d64b4 https://medicaldevicecourses.com/activity/p/16252/ Wed, 15 May 2019 19:37:28 -0400 One of the projects I worked on was to create an on-site document to manage our special processes, casting, hot isostatic pressing and solution annealing. This involved closely working with a statistics expert in Warsaw. One of the biggest obstacles…   Read more»

]]> ff0608d1716f915d01c7b4029d0ed0a7 https://medicaldevicecourses.com/activity/p/16248/ Wed, 15 May 2019 19:37:26 -0400 The best work dynamic for a medical device project is a team whose members trust each other and have an ownership mentality. Each member should contribute to the project. It is important to have someone lead the project which a…   Read more»

]]> 0c684ce8ef3c090046ca34e3f09b4df7 https://medicaldevicecourses.com/activity/p/16135/ Wed, 15 May 2019 19:17:31 -0400 I have had the opportunity to work in the industry as well as academia. I worked as a research assistant under a PhD student for a year. A lot of times, working in academia can mean repetitive work. This is…   Read more»

]]> a3ff7cd1cc9967d78b4e7cf9095b9ea7 https://medicaldevicecourses.com/activity/p/16132/ Wed, 15 May 2019 19:17:29 -0400 I am a non-traditional BME Student. One major advice I can offer is said above in almost every comment which is to get a co-op/internship. Real word experience is very different from what we learn in our classes in school….   Read more»

]]> 25bb7d82e754ea7033f030d352d36190 https://medicaldevicecourses.com/activity/p/16128/ Wed, 15 May 2019 19:17:25 -0400 In my experience so far in the BME field, there are more cons than pros. One of the cons is what you mentioned above, BME is too broad. In the company I worked for, a lot of the engineers studied…   Read more»

]]> 3e501cfaee5790d9248aecbbdaf7fcff https://medicaldevicecourses.com/activity/p/16008/ Wed, 15 May 2019 19:16:07 -0400 I currently work in the industry, so a lot of the things mentioned here were familiar. This class has allowed me to understand the processes and procedures in medical device better. This class also helped me understand what goes on…   Read more»

]]> 1cf20f2cad90caad4cb7797ff3d584c6 https://medicaldevicecourses.com/activity/p/16007/ Wed, 15 May 2019 19:16:06 -0400 I learned the importance of a team. I learned that a successful project starts with a team that is willing to communicate and work together to achieve a common goal. I also learnt how important your social skills are in…   Read more»

]]> aa947414a532e783fca2096efbb97ab1 https://medicaldevicecourses.com/activity/p/15890/ Wed, 15 May 2019 19:15:00 -0400 I am motivated by challenges and learning constantly. I love being given several task and deadlines and meeting them on time. I take every opportunity I can to learn. So I try to finish the project assigned to me as…   Read more»

]]> a5ed07ae349ecf955bd2f2c6fc998eaa https://medicaldevicecourses.com/activity/p/15889/ Wed, 15 May 2019 19:15:00 -0400 I believe American’s overworking is a mix between motivation and just having too much work to do. Right now because I am young and new to the field, I enjoy being given tons of task and responsibilities. I end up…   Read more»

]]> 60f02377cf23b43c2c74ca361022c600 https://medicaldevicecourses.com/activity/p/15888/ Wed, 15 May 2019 19:14:59 -0400 I would say at the moment, I would want to work as an engineer. I have been in the field for less than a year and I noticed manager’s do more paperwork while the engineers are more hands on. I…   Read more»

]]> fe004cb40945c90e72677dfba29365f6 https://medicaldevicecourses.com/activity/p/15762/ Wed, 15 May 2019 19:13:39 -0400 Human resource management is extremely important. I recently started working for a new company and HR is in charge of finding the best fit for open positions. It seems that some of the operators/technicians that were hired were not a…   Read more»

]]> 17faed42de73c853de697580f7b0197e https://medicaldevicecourses.com/activity/p/15759/ Wed, 15 May 2019 19:13:37 -0400 I would say that a company should have a communication management plan and document it as an SOP. It should be a broad plan though and include what every communication plan would have. So with different projects, the team should…   Read more»

]]> c190cca5d19a38a018b9eadec177046b https://medicaldevicecourses.com/activity/p/15757/ Wed, 15 May 2019 19:13:36 -0400 Adding on to what as934 said above, a good contract should also include quality criteria, clarification of ownership, defined deliverables and review period, and any changes (as as934 listed above). From previous experience, usually a supplier will have one thing…   Read more»

]]> 7bb1242c8dc55acdd31e5c459891c805 https://medicaldevicecourses.com/activity/p/15619/ Wed, 15 May 2019 19:08:19 -0400 I currently work at an orthopedic company. We recently had to make an update to insert a class III PMA logo for all level III medical device. Since I had to go through several devices, I did not want to…   Read more»

]]> 2efa7d82938aeb09ac062c334432513d https://medicaldevicecourses.com/activity/p/15616/ Wed, 15 May 2019 19:08:17 -0400 These factors each contribute to the success of a project. For example, if a team is unable to effectively communicate than the project will not be done at a mannerly time and it would be difficult to coordinate roles and…   Read more»

]]> 8c79f2a92cba4c34a9113cf4c0567de6 https://medicaldevicecourses.com/activity/p/15514/ Wed, 15 May 2019 19:07:10 -0400 Adding on to what bnb6 said above, I looked up some metrics that would be beneficial for project management. The first one is productivity, this compares the total effort to the budgeted effort. The second one is cost. The third…   Read more»

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