https://medicaldevicecourses.com/members/bb254/activity/ Activity feed for bb254. Fri, 24 Apr 2026 13:59:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 84fe00301e398518690a98505aa1472d https://medicaldevicecourses.com/activity/p/16025/ Wed, 15 May 2019 19:16:15 -0400 I believe that it is the responsibility of the manufacturer to notifying the user of any side effects or risks with the drug being administered. A study can be shutdown for several reasons, one being cross contamination. A recent article…   Read more»

]]> b53722078e944b6893d5a8b19441d2a0 https://medicaldevicecourses.com/activity/p/16023/ Wed, 15 May 2019 19:16:14 -0400 Out of all my entire bachelors and masters courses there are only a handful of courses which gave me insight to what it is like to work as a biomedical engineer. AMDD is one of those classes, that material we…   Read more»

]]> 0ae22d1d86bfbe2265e8a2d88c2d3254 https://medicaldevicecourses.com/activity/p/16021/ Wed, 15 May 2019 19:16:13 -0400 The simulations are a great way to engage students into a work environment within the medical device industry. It allows students to apply the knowledge they gained within the lectures to real life scenarios that are common in the world….   Read more»

]]> 37e8476d072d9b851875de854dd51b55 https://medicaldevicecourses.com/activity/p/15898/ Wed, 15 May 2019 19:15:04 -0400 The cost of a study is dependent on the location of the study, however, the prime reason for a study conducted outside of the U.S is not cost. The research must be associated with the region the study is being…   Read more»

]]> b09926d5e5116d448102804371bb30ba https://medicaldevicecourses.com/activity/p/15897/ Wed, 15 May 2019 19:15:04 -0400 The first medical product that comes to mind when I heard of significant risk is a pacemaker. It is an implant which contains an electrical circuit that sends electrical impulses to the heart. My father has a pacemaker and it…   Read more»

]]> 49781a3b46fd6eff5f981389f8bd5cbe https://medicaldevicecourses.com/activity/p/15896/ Wed, 15 May 2019 19:15:03 -0400 I never saw myself in the career path of clinical research due to the constant need for travel. I was interested in a period of time in the career path of research, so I interned within the human performance lab…   Read more»

]]> 39323b0c6d73bc2df2ea864ae7f43668 https://medicaldevicecourses.com/activity/p/15692/ Wed, 15 May 2019 19:12:56 -0400 Recently, we received notification of a nonconformance within our instructions for use document which is sold in one of our major product lines. It escalated to a CAPA and HHE. A section of the document was inadvertently omitted. A complete…   Read more»

]]> 6260d5988cb07815906a0bc46ab73731 https://medicaldevicecourses.com/activity/p/15688/ Wed, 15 May 2019 19:12:54 -0400 From my experience, GMP (good manufacturing practices) quality system documents are general but clear. As a new employee, the company trains you on the GMP regulations that the company upholds. If there are discrepancies, then many of the other employees…   Read more»

]]> 38a5abf822cad230674f156728c7877d https://medicaldevicecourses.com/activity/p/15687/ Wed, 15 May 2019 19:12:53 -0400 GMP represent good manufacturing practices, all medical companies have a list of regulations for there standards for good manufacturing practices. The company I work for has not updated the GMP quality system document for a while. The reason is because…   Read more»

]]> 92c20eff64425c1824dc4466ad3b3703 https://medicaldevicecourses.com/activity/p/15608/ Wed, 15 May 2019 19:08:11 -0400 During my time at my company, I have not experienced a period when sales were on a decline. However, coworkers have told me what the company did in the past when the sales weren’t good. Upper management met up and…   Read more»

]]> fcfc48cdbc97bdae3708da488bb3ec70 https://medicaldevicecourses.com/activity/p/15607/ Wed, 15 May 2019 19:08:10 -0400 The development phase is the most expensive phase within product life cycle. The development phase requires testing and creation of the products. Within an undergrad course that I took, we had to develop a product that fulfills a current market…   Read more»

]]> b294edc6ef2fbabe3ed8f533ab16a3f6 https://medicaldevicecourses.com/activity/p/15606/ Wed, 15 May 2019 19:08:09 -0400 I have gone through the scenario where a project was to increase sales but in the middle of the project the marketplace was no longer attractive to the project goal. As a result, many meetings were scheduled to discuss the…   Read more»

]]> a9bf60678fa48f92e12d446e2f611917 https://medicaldevicecourses.com/activity/p/15494/ Wed, 15 May 2019 19:06:59 -0400 My first project as a Biomedical Engineer was to obsolete a product line that was sold to Japan. Based off marketing’s decision the cost to produce the product did not match the profit compared to other product lines that the…   Read more»

]]> a6bf8962ae75cc4c4638e0e1faa1660d https://medicaldevicecourses.com/activity/p/15493/ Wed, 15 May 2019 19:06:58 -0400 From experience, a project manager should be well informed of the current industry and market data that their product is apart of. The medical device industry is always growing and the need for medical products will always be a necessity….   Read more»

]]> 96f9b565eada43f7e761e449635bcecf https://medicaldevicecourses.com/activity/p/15492/ Wed, 15 May 2019 19:06:58 -0400 When deciding to sign a contract with a customer you need both interpersonal skills and business knowledge. From experience working with suppliers, you need to be knowledgeable of the product, risks, financial obligations required in persuading your team and vendor…   Read more»

]]> 3bbb7eaf291f93ae67be13b3ef2ea238 https://medicaldevicecourses.com/activity/p/15309/ Wed, 15 May 2019 19:05:05 -0400 Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we rely on validation for new fixtures and processes. Verification are stated in…   Read more»

]]> 02ac8e605b3f000365c820c3bf068bbc https://medicaldevicecourses.com/activity/p/15307/ Wed, 15 May 2019 19:05:04 -0400 I never came across an expiration date for a validation. If an equipment was validated 30+ years ago and is still operational without any new changes to the fixture than the original validation is still valid. The only instances that…   Read more»

]]> de336801f62a9387b7096eab0596023b https://medicaldevicecourses.com/activity/p/15306/ Wed, 15 May 2019 19:05:04 -0400 From a medical device company perspective, it is better to have preventative CAPAs than reactive CAPAs. At my current employment, we have both preventative and reactive CAPAs. In recent meetings our manager began giving out multiple preventative CAPAs to balance…   Read more»

]]> 5806c9b42d38bdd9fde80b8fb2826e62 https://medicaldevicecourses.com/activity/p/15189/ Wed, 15 May 2019 19:03:49 -0400 Technical Writing courses are not given to students as a priority when in actuality the work industry requires an individual with good technical writing skills. When starting a full-time position as an engineer, I had to validate a new automatic…   Read more»

]]> c7b13c6fd00d98cba48a36de16a5e354 https://medicaldevicecourses.com/activity/p/15188/ Wed, 15 May 2019 19:03:49 -0400 When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture. If so, then it can escalate to a CAPA through the development of…   Read more»

]]> 3a707a7fb82a54bdbd90a40fc9f63015 https://medicaldevicecourses.com/activity/p/15186/ Wed, 15 May 2019 19:03:48 -0400 Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one of Dr.Simon’s courses my spring semester I knew that in order to get…   Read more»

]]> 95fd914df2007ca086050d62dda585a9 https://medicaldevicecourses.com/activity/p/15067/ Wed, 15 May 2019 19:02:45 -0400 As many of you know, when you get hired as an engineer the first couple of weeks are dedicated to being trained per the SOP’s of the company. Therefore, as a startup company, the employees will learn the standards of…   Read more»

]]> 8a9d1d6188fcbc7ffea2d24da28fa9e5 https://medicaldevicecourses.com/activity/p/15066/ Wed, 15 May 2019 19:02:44 -0400 While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. This does create traceability however it ends up creating a lot more work in the long run. Just…   Read more»

]]> 31435833c1fecfe9fc411ac312b89992 https://medicaldevicecourses.com/activity/p/15065/ Wed, 15 May 2019 19:02:44 -0400 SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, procedure, documents/ fixtures affected, forms and attachment sections. All SOPs should be written in a concise…   Read more»

]]> 224d6dfcc2dd90d6993d69fdba475852 https://medicaldevicecourses.com/activity/p/14962/ Wed, 15 May 2019 19:01:45 -0400 SOPs are grilled into engineers minds ever since their first day at work. Within the medical company I work at it is mandated to have SOPs for every fixture or process that is in place. It is not just focused…   Read more»

]]> f9cc9c85933c161992ebeb6aa74b0938 https://medicaldevicecourses.com/activity/p/14961/ Wed, 15 May 2019 19:01:45 -0400 The current company that I work for uses ECOs in the form of change notices as Julienne has stated above. The process of implementing a change within an SOP requires engineering to supply a redline and final draft of the…   Read more»

]]> 7d0411a723cd3c5b61f6606ff6bed2f5 https://medicaldevicecourses.com/activity/p/14959/ Wed, 15 May 2019 19:01:44 -0400 One advice that my manager told me when dealing with a complete rewrite of an SOP or creating and SOP is to make it “idiot proof”. This terminology is used to make it clear that whatever is being stated in…   Read more»

]]> a1e23fe98c9ca82f8c883cff6c7be879 https://medicaldevicecourses.com/activity/p/14870/ Wed, 15 May 2019 19:00:56 -0400 The company I work for does utilize a Design Specification document as Dr. Simon had described in this week’s lecture. It includes a design matrix that traces the entire process of the design. It is a living documents therefore it…   Read more»

]]> 1c60dc31e45c7b7a7ec793a1064fe283 https://medicaldevicecourses.com/activity/p/14869/ Wed, 15 May 2019 19:00:55 -0400 From prior experience, when a verification/validation had failed I was obligated to redo the verification and validation per the updated specification. Yes, this is time consuming and can be costly, but it is the cleanest way to reroute the protocols….   Read more»

]]> aaf1300fedc96292e66dc2b75f28a6e4 https://medicaldevicecourses.com/activity/p/14858/ Wed, 15 May 2019 19:00:50 -0400 Document History File is more useful than a Tech File in terms of traceability. Document History File is a living document, it contains any mistakes or scrapped information that were made along the process of designing the device. A Tech…   Read more»

]]> 240a3f4855b59d17993b8ead8960945f https://medicaldevicecourses.com/activity/p/14696/ Wed, 15 May 2019 18:59:16 -0400 Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based on standards. The council approves the directives but does not state how to enforce the law….   Read more»

]]> 58394cb175170685576f4d6caccd3d45 https://medicaldevicecourses.com/activity/p/14695/ Wed, 15 May 2019 18:59:16 -0400 I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A cardiovascular medical device that I love learning about it the pacemaker. A pacemaker is considered in the…   Read more»

]]> 7e01635cdd03ba495381900e67b0e76b https://medicaldevicecourses.com/activity/p/14691/ Wed, 15 May 2019 18:59:14 -0400 Based on this weeks lecture the EU regulatory focuses on risk and essential requirements checklist. The FDA analyzes more so on efficacy and the FDA makes the sole decision on if the medical device meets the regulations. EU regulatory is…   Read more»

]]> a1225d49b36d18da5cf0aa7d5d2870fe https://medicaldevicecourses.com/activity/p/14542/ Wed, 15 May 2019 18:57:51 -0400 One of the major marketing strategies used within the company I work at is the fifth P. Our products are mostly used by surgeons and physicians; therefore, the marketing group will hold meetings with hospitals to discuss the product. The…   Read more»

]]> 373ef4dc0a23c881c3aeda844023ecfe https://medicaldevicecourses.com/activity/p/14540/ Wed, 15 May 2019 18:57:50 -0400 Personally, I have not experienced working out a legal contract at work first hand. However, I was informed that our company had a major fall through with a legal contract with a warehouse that distributes our main products. The timeframe…   Read more»

]]> 9848a9e4776b94145005b3d3f9799b6e https://medicaldevicecourses.com/activity/p/14539/ Wed, 15 May 2019 18:57:49 -0400 Two years ago, I was working in a human performance lab that was gathering data on neuromuscular activity from patients after chemo treatments. The focus of the research was to see how chemotherapy from breast cancer survivors has affected neuromuscular…   Read more»

]]> c6ac1a686e8e0d1c559e4bfebc9c12f1 https://medicaldevicecourses.com/activity/p/14463/ Wed, 15 May 2019 18:57:11 -0400 I never directly dealt with a non-compete agreement but my brother in law has. He signed the agreement two years ago and found out recently the consequences of it. When he decided to defer his contract, he was obligated to…   Read more»

]]> e1f93aedb9aaabb8d8fef63474d95525 https://medicaldevicecourses.com/activity/p/14450/ Wed, 15 May 2019 18:57:05 -0400 Verbal agreements much be accepted by the law, but I was always taught that “if you don’t have it in writing then it doesn’t mean anything.” This saying comes into use whenever I work on a project. Whenever I have…   Read more»

]]> f4f7318ef9c99bd3a7e17a60b09e258f https://medicaldevicecourses.com/activity/p/14448/ Wed, 15 May 2019 18:57:04 -0400 This course was very beneficial in learning about the different design controls, business and regulatory aspects of the medical device industry. I previously took your project management course and preferred that structure of the course over the medical device course….   Read more»

]]> 9ca7d3c7d237d3891d4a2c26cefa60e3 https://medicaldevicecourses.com/activity/p/14287/ Wed, 15 May 2019 18:54:47 -0400 Based on my experience, a functional organization seems to work well in large companies. Yes, a disadvantage is the creation of silos but that can always be resolved. Having an IT, marketing, finance, quality, manufacturing departments allows the members of…   Read more»

]]> 6b71f2328f0342746f62ec611fc69d8b https://medicaldevicecourses.com/activity/p/14280/ Wed, 15 May 2019 18:54:43 -0400 I work as a product engineer at a company which has a matrix organization and the one constant is disagreements between departments. Whenever we have a major project we have meetings with the lead of each department to discuss the…   Read more»

]]> d8e08f37b07ddcff8844499bf3c6cb9e https://medicaldevicecourses.com/activity/p/14277/ Wed, 15 May 2019 18:54:41 -0400 As an undergraduate I had to form a project team for a senior design project and I formed a group with two other friends. I worked with these two friends previously on other projects and we worked extremely well with…   Read more»

]]> 586c12b43c7277836979bf2594a71868 https://medicaldevicecourses.com/activity/p/14141/ Wed, 15 May 2019 18:52:24 -0400 At Getinge, the sample size is determined mostly from the risk index. Since Getinge’s main acute therapy product is Intra-aortic balloons the risk index significantly changes the sample size while running a protocol. Recently, I was helping a senior engineer…   Read more»

]]> 7bca34ae2e6daa1f43ae9f4901aa17e1 https://medicaldevicecourses.com/activity/p/14139/ Wed, 15 May 2019 18:52:23 -0400 As a co-op at Getinge I was able to work on a project associated with updating the PFMEA (process failure mode effects analysis). This one document lays out each process for creating the final medical device for each product line…   Read more»

]]> bff393a7f24a242ad82d3bb19479fa68 https://medicaldevicecourses.com/activity/p/14137/ Wed, 15 May 2019 18:52:22 -0400 The ISO 14971:2012 risk management requirement is not clear because one cannot define” as far as possible.” The risk management team can find ways to mitigate, eliminate, prepare for risks which can have an economic effect on the medical device….   Read more»

]]> 7cb01bec2dab495a6c62120b3efc44c7 https://medicaldevicecourses.com/activity/p/14010/ Wed, 15 May 2019 17:10:23 -0400 Deviations that come from the verification step of a design control always causes a havoc at work. Recently, I was trying to qualify a modified fixture for use on the production floor. The drawing was completed, the fixture was built…   Read more»

]]> 9d35af8bafd526d23d7e0079545875e6 https://medicaldevicecourses.com/activity/p/14008/ Wed, 15 May 2019 17:10:22 -0400 I am a production engineer at Getinge, and last week was my first time leading a design review meeting. The preparation for my design review meeting was intense since I was covering phases I-III in one meeting. I had to…   Read more»

]]> d37862f1203b1cd2692fc68bb6f9e247 https://medicaldevicecourses.com/activity/p/13813/ Wed, 15 May 2019 17:08:27 -0400 I completed my undergrad at NJIT and within the senior design course (capstone) I developed a better understanding of what a requirement and test plan document contains. It was grilled into my head that every time you write a document…   Read more»

]]> 93e6550a5e903bbd71587b166d0d28ac https://medicaldevicecourses.com/activity/p/13812/ Wed, 15 May 2019 17:08:26 -0400 Within the medical industry it is crucial to always have the DHF updated as the progress of the project moves forward. A way to make sure that your documents within the DHF are ready for an audit is to have…   Read more»

]]> a2b8a198aac998fa7ac08c97c8c0faed https://medicaldevicecourses.com/activity/p/13810/ Wed, 15 May 2019 17:08:25 -0400 Currently, I work in the medical industry as a production engineer. I am working on a global project that deals with four of our product lines that will implement a global labeling change. Therefore, several engineers, managers, researchers from different…   Read more»

]]>