https://medicaldevicecourses.com/members/mrela13/activity/ Activity feed for mcr29. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e38354669c228a5adc4595d9c34ad392 https://medicaldevicecourses.com/activity/p/24170/ Sat, 11 Dec 2021 03:57:51 -0500 An NDA is by no means a substitute for a patent. A patent is something that is essentially purchased from the government to protect your ideas from being directly copied and used to make profit off of. An NDA is…   Read more»

]]> d6b4d018a22a8ac3758215083b459035 https://medicaldevicecourses.com/activity/p/24169/ Sat, 11 Dec 2021 03:47:25 -0500 I just had a friend who was laid off from my company due to cut backs in the remediation budget. Now that our remediation project has come to a close, those who were hired as a part of that budget…   Read more»

]]> 274f20ba0e9416a9142e1edbf4909a37 https://medicaldevicecourses.com/activity/p/24168/ Sat, 11 Dec 2021 03:31:47 -0500 While working at my company, we had discovered some problems with our injection molding system during a re-validation. While using the same injection molder and the same settings, we were getting a different outcome from the normal plastic pieces we…   Read more»

]]> 8204f9224ba9a46d007b3c0e3ef4e754 https://medicaldevicecourses.com/activity/p/24167/ Sat, 11 Dec 2021 03:24:42 -0500 Most of the time the type of team that is created for a role depends on the project that they are working on. In some projects it may be better to have a group with similar ideas to you where…   Read more»

]]> 0d9d5181edd595b5094ed08d3cd1a9f6 https://medicaldevicecourses.com/activity/p/24166/ Sat, 11 Dec 2021 03:15:20 -0500 In my experience, working on collaboration projects does not really have anything to do with organizational structure. As Adrian stated above, it has a lot more to do with the culture of the employees, the processes in place, and the…   Read more»

]]> bed801b0eec0cac3c914ae2a2c8c4030 https://medicaldevicecourses.com/activity/p/24165/ Sat, 11 Dec 2021 02:55:45 -0500 Personally, I see myself being much more effective in a middle management role than an upper management role. Not that I don’t think I could be in upper management, but I think my working style is more effective when actively…   Read more»

]]> 39314e8bfe69e7aaf17a49693a693fe2 https://medicaldevicecourses.com/activity/p/24164/ Sat, 11 Dec 2021 02:49:00 -0500 For risk management a FMEA is the best tool to use as it includes multiple components of each risk and classifies the risk based on occurrence, severity, and detection. It also allows engineers to track possible failure modes based on…   Read more»

]]> 152920fd5d4cb311a2f3484dc12a1f8e https://medicaldevicecourses.com/activity/p/24163/ Sat, 11 Dec 2021 02:25:48 -0500 While working for my company, we do our best to handle risks as appropriately as possible. From an auditor point of view and our companies general view on risk, it is not satisfactory for us to accept risk for our…   Read more»

]]> 887dbfece72cce65c8d425e7d0c7a214 https://medicaldevicecourses.com/activity/p/24162/ Sat, 11 Dec 2021 02:12:14 -0500 While working at my current company I have been able to work on a PFMEA for a product that will be coming out for release. Luckily for me, this product was very similar to one we already produced, but required…   Read more»

]]> e5a69e9319cebd5d2339e04596dd0931 https://medicaldevicecourses.com/activity/p/24161/ Sat, 11 Dec 2021 01:38:40 -0500 Yes, I believe that placebo controlled trials are ethical and are very necessary to ensure that drugs and treatments are both effective and not creating fake results. This may seem like it is cruel, because some people are signing up…   Read more»

]]> 14621b49acb747027b873d139da094ce https://medicaldevicecourses.com/activity/p/24160/ Sat, 11 Dec 2021 01:06:35 -0500 @sseal98 I agree that underlying conditions play the biggest role in how COVID is affecting individuals when it comes to severity of illness and how likely an individual is to be hospitalized or have mild symptoms. At the same time,…   Read more»

]]> 8403d3a0577322c71a4a9a417cd386ce https://medicaldevicecourses.com/activity/p/24159/ Sat, 11 Dec 2021 00:51:45 -0500 A double blind study has a lot of benefits in clinical trials where the people running the study want every part of the study to be impartial. I think most can agree that if a single blind study is complete…   Read more»

]]> 8cb6b4fd7578a6fe0c8ec6f3ae151de6 https://medicaldevicecourses.com/activity/p/24158/ Fri, 10 Dec 2021 23:57:18 -0500 One of my favorite commercials is the Mean Joe Greene Super Bowl commercial from Coca Cola. This commercial included aspects of marketing which draw most viewers to products. It included a big name athlete who was a role model in…   Read more»

]]> 096c02406eacf5f355fbc274ac243cf9 https://medicaldevicecourses.com/activity/p/24157/ Fri, 10 Dec 2021 03:50:46 -0500 If I am developing a company that provides dental tools, my main client would be the dentist that will be using the tool to complete the procedure/treatment. When it comes to dentistry, there tools are not normally sold in retail…   Read more»

]]> bdbfac89f1ce571912e6bb66a6664607 https://medicaldevicecourses.com/activity/p/24156/ Fri, 10 Dec 2021 03:39:31 -0500 So far in my career I have worked for two different types of companies. My first job was working for a sole proprietorship in a small water purification company with less than 10 employees. My second is for a large…   Read more»

]]> 799b2d3b042e2639ffa0c576df73bf3d https://medicaldevicecourses.com/activity/p/24155/ Fri, 10 Dec 2021 03:24:14 -0500 In working for a publicly owned company, engineers are not that involved with the opinions of shareholders unless their project holds a lot of weight for the company. For example, if there is a new project launch that the company…   Read more»

]]> 1269ae29a71b50594279841f90ee5c63 https://medicaldevicecourses.com/activity/p/24154/ Fri, 10 Dec 2021 03:12:39 -0500 If I had ownership of my own company, I would definitely prefer to own it as a sole proprietor rather than anything else. I would do this to have total control over the company and be able to run it…   Read more»

]]> 2c9402127729b77746e11f18beb1352e https://medicaldevicecourses.com/activity/p/23909/ Mon, 01 Nov 2021 03:12:51 -0400 When it comes to statistical sampling there are a few factors to consider when writing protocols. One of the main factors is what kind of protocol is being written. Most of my experience is with process validations, so I write…   Read more»

]]> 782d18da9b9b760d7c2f52d7e6813649 https://medicaldevicecourses.com/activity/p/23908/ Mon, 01 Nov 2021 03:01:02 -0400 The steps of process validation for a process include Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and sometimes a Process Performance Qualification (PPQ). The first step of any process validation is to run an IQ. This is basically…   Read more»

]]> 01bc1aed962507420290bb043903e544 https://medicaldevicecourses.com/activity/p/23906/ Mon, 01 Nov 2021 02:49:04 -0400 Throughout my time working at a company I have done many different types of validations. Essentially, validations can be done for a large array of tests and products or processes. One type that I have done is a packaging validation…   Read more»

]]> 17114827dd91412b1277304450416ab6 https://medicaldevicecourses.com/activity/p/23727/ Fri, 15 Oct 2021 02:18:55 -0400 In my opinion, one of the biggest improvements that needs to be made to most quality departments, especially at my company, is the communication between quality and manufacturing. A lot of times, quality thinks they have the final say on…   Read more»

]]> 5e844a4b94c21e797c54bbeef9fd4b87 https://medicaldevicecourses.com/activity/p/23726/ Fri, 15 Oct 2021 01:51:52 -0400 At my company I have worked with R&D on many issues which Quality was also involved. As stated by @dbonanno1, R&D and Quality had very different opinions on how to handle most situations, R&D coming from a view of practicality…   Read more»

]]> 78a3f1195a94d4b8e2044ba38c852c25 https://medicaldevicecourses.com/activity/p/23724/ Fri, 15 Oct 2021 01:15:02 -0400 Like @bb254, I also work for a company that has a document control system that wastes a large amount of time and resources. While I understand the need for a quality management system and the need for quality to review…   Read more»

]]> a7629dc9066ad9f2ba12aa805692497e https://medicaldevicecourses.com/activity/p/23723/ Fri, 15 Oct 2021 00:53:15 -0400 Human differences can be very beneficial to producing medical devices, but they can also have their drawbacks. When it comes to engineering itself, differences in thoughts, perspective and experiences can be a huge benefit looking at development from different angles….   Read more»

]]> 3e5320fb3a7d43f23d8482fff8a0f9ac https://medicaldevicecourses.com/activity/p/23722/ Fri, 15 Oct 2021 00:39:57 -0400 There are many drugs and medical devices that are manufactured and sold in other countries that are currently banned in the US or not allowed to be manufactured in the US. The main reason for this is because the FDA…   Read more»

]]> 3935ee747a079c585468ecaba76a23ac https://medicaldevicecourses.com/activity/p/23721/ Fri, 15 Oct 2021 00:14:13 -0400 In academia, research is much more based on the love of knowledge and advancement then it is on how much the research can increase profit or productivity. As Professor Simon suggested in the lecture, most members of academia generally research…   Read more»

]]> 91b91b6446e2aceef92996fcc49f2829 https://medicaldevicecourses.com/activity/p/23600/ Mon, 04 Oct 2021 22:59:17 -0400 While I do think the FDA is very strict, the drugs and devices that they are regulating affect millions of people. That being said, without regulations and strict rules, some of these devices could be harming more individuals then they…   Read more»

]]> 8c58f31245126463f00fe3be2508b6c9 https://medicaldevicecourses.com/activity/p/23410/ Tue, 21 Sep 2021 00:11:47 -0400 @cruzdonato I do not think it is okay to cut corners while doing any type of testing that could provide you with valuable information on how safe or functional a medical device is. Especially devices that are going to remain…   Read more»

]]> 9eed19c58b5230f224ecd6567877010a https://medicaldevicecourses.com/activity/p/23409/ Tue, 21 Sep 2021 00:11:44 -0400 @cruzdonato I do not think it is okay to cut corners while doing any type of testing that could provide you with valuable information on how safe or functional a medical device is. Especially devices that are going to remain…   Read more»

]]> d32f570e3908569e78064f47ddab655c https://medicaldevicecourses.com/activity/p/23407/ Mon, 20 Sep 2021 23:51:33 -0400 I currently work in industry now and I can tell you that I am very happy with my choice. As someone who has always enjoyed starting a project and seeing it all the way through until the final product, it…   Read more»

]]> ae4d14d1e3302efb3e99664875646bee https://medicaldevicecourses.com/activity/p/23245/ Sat, 11 Sep 2021 00:55:04 -0400 I have been working under my first project manager for about three years now. My manager almost acts like more of a friend to me than a manager. He is very hands off and trusts me to get a lot…   Read more»

]]> be79701036588373036e0d3b0599f1e6 https://medicaldevicecourses.com/activity/p/23243/ Sat, 11 Sep 2021 00:33:12 -0400 I have not been the manager of any projects, but my boss and I communicate a lot about the projects that he manages. The quick and easy response to this is that it is almost impossible to predict all of…   Read more»

]]> ca993a7a57ed4a5b1bbfa22388ca0923 https://medicaldevicecourses.com/activity/p/23242/ Sat, 11 Sep 2021 00:23:47 -0400 In a medical device company, the best dynamic to have between a manager and an engineer is mutual respect for one another. At my company, my manager and I not only have a mutual respect for each other, but trust…   Read more»

]]> 042ad2d380f7f151bf69c1d71b1a9400 https://medicaldevicecourses.com/activity/p/23195/ Tue, 07 Sep 2021 01:09:04 -0400 Being a relatively recent graduate and having worked in the medical device field, doing a large amount of process and equipment validation, I have found that a lot of engineers have trouble applying the knowledge they have learned in school…   Read more»

]]> 28ddde54ba4e18ea9e6f91f869b816a9 https://medicaldevicecourses.com/activity/p/23194/ Tue, 07 Sep 2021 01:09:04 -0400 From my experience in the industry, all that you need to enter the industry is a BS degree, a willingness to learn as much as possible, and some good connections. While there are some companies that are looking for someone…   Read more»

]]> 7ce61af4d5aa171a32a3878a29f8d8ea https://medicaldevicecourses.com/activity/p/23191/ Tue, 07 Sep 2021 01:09:02 -0400 In agreeance with a lot of people who have posted here, experience is everything, especially when it comes to FDA regulations and guidelines, design controls, and process validation. When I was a junior in college, I had been working for…   Read more»

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