https://medicaldevicecourses.com/members/neb2/activity/ Activity feed for neb2. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ecb7637c66b3a7f56db6f8bc43491a4f https://medicaldevicecourses.com/activity/p/12611/ Wed, 15 May 2019 16:57:34 -0400 I do agree with the above posts up to a certain extent. Yes the testing portion of any trial can be very time consuming and daunting but accomplishing your goals is the most rewarding. Ideally in a R&D facility, engineers…   Read more»

]]> c971569930eb411ec648c1cb88b32311 https://medicaldevicecourses.com/activity/p/12564/ Wed, 15 May 2019 16:57:10 -0400 I agree with the comments above. These simulations helped me understand how engineers have to solve issues on a daily basis. From simulation 1 to simulation 3, I had the opportunity of putting in practice every lecture learned throughout the…   Read more»

]]> c74c966272f7b208bf3b3abd2073f12b https://medicaldevicecourses.com/activity/p/12563/ Wed, 15 May 2019 16:57:10 -0400 I think the combination of the course options we have is sufficient since we get a taste of statistical analysis, CAD design, Coding (Labview/Matlab), & medical device development. With this being said, we get a opportunity to take two classes…   Read more»

]]> 018a0c5c16d77f531da88b5de6df788f https://medicaldevicecourses.com/activity/p/12478/ Wed, 15 May 2019 16:56:23 -0400 I do think that maintaining the budget of a clinical study could lead organizations to conduct the studies in developing countries to save on costs. Balancing funding with results might not be easy since it could be difficult to plan…   Read more»

]]> 13ef29155316ddc46b369f5a61343f3b https://medicaldevicecourses.com/activity/p/12477/ Wed, 15 May 2019 16:56:23 -0400 I have not had any experience yet on clinical studies but I would like to develop a little more on blinded clinical studies. In this type of study, subjects are blind to which treatment is given. There are three types…   Read more»

]]> 2a4d17ed7f8030c14df2cb2cac3eefd7 https://medicaldevicecourses.com/activity/p/12361/ Wed, 15 May 2019 16:55:18 -0400 Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete in order to “stay compliant,” while others look at CAPAs…   Read more»

]]> 33efb35112f629106311eb28e6ba3fd1 https://medicaldevicecourses.com/activity/p/12360/ Wed, 15 May 2019 16:55:17 -0400 Recently at work, we faced that most real time products coming out of the chamber were dictated as non-conforming upon pressure decay testing. At first, R&D engineers thought that probably the technician was not performing the test as specified in…   Read more»

]]> e1c24ab5d57024c880470942115932ce https://medicaldevicecourses.com/activity/p/12333/ Wed, 15 May 2019 16:55:03 -0400 GMP’s ambiguity does make it more difficult for startup companies. These companies could have the required description in order to have a compliant quality system but they do not have an pre-existing framework that they could follow. Therefore, creating quality…   Read more»

]]> 49647baca4330142b6787304e51e4a89 https://medicaldevicecourses.com/activity/p/12328/ Wed, 15 May 2019 16:54:55 -0400 No GMP will certainly result in a cheaper process and the product will also sell at a lower price. Nevertheless, GMPs is what establish your credibility to other organizations, to your customers. It proves that you are a viable supplier…   Read more»

]]> 785dc03c7695e83c407e2bd416065fb8 https://medicaldevicecourses.com/activity/p/12262/ Wed, 15 May 2019 16:54:17 -0400 Product failure can be described in two categories; product risk & business risk. Product failure is not a fun thing to deal with and a lot of companies deal with it in different ways. Some companies have a non-conformance tracking…   Read more»

]]> 1b2870989b302fd145af7ebd52f59739 https://medicaldevicecourses.com/activity/p/12261/ Wed, 15 May 2019 16:54:17 -0400 Interpersonal skills and business skills vary from one company to another specially in medical device fields where it’s not so easy to do everything yourself with all the ISO & FDA regulations. I’ve seen and heard about companies that take…   Read more»

]]> a49ec648eb3d2efb31ea97860f57a8a2 https://medicaldevicecourses.com/activity/p/12260/ Wed, 15 May 2019 16:54:16 -0400 In my opinion, there is really no scrap of a project due to patent issues or money. There is always a priority change in which project management plays a huge role depending on the business needs. I’ve seen some products…   Read more»

]]> 28a7747732a37441000fd5a59a7f7da6 https://medicaldevicecourses.com/activity/p/12191/ Wed, 15 May 2019 16:53:38 -0400 During post-launch product management, it is very important to keep track of the product’s quality performance by interacting with the customers and keep track of it. This way you are ensuring that customers are not only satisfied with the new…   Read more»

]]> 26b12efc7db82395f7a5ca7c3e9a5554 https://medicaldevicecourses.com/activity/p/12187/ Wed, 15 May 2019 16:53:36 -0400 Hi gh56, I do not experience on this area yet. Nevertheless, I believe that it is difficult to pinpoint any role as the most important role for a product manager since they are equally important and they all relate to…   Read more»

]]> a457a134a16a880aebcddcfe15fda55c https://medicaldevicecourses.com/activity/p/12075/ Wed, 15 May 2019 16:52:34 -0400 If the machine severely failed in manufacturing, the first step is to investigate the root cause of the failure. Once the root cause has been found, a correction must be performed. If the failure can have a product risk then…   Read more»

]]> 75a3b7d8f90509d743dca3384d95f26a https://medicaldevicecourses.com/activity/p/12067/ Wed, 15 May 2019 16:52:30 -0400 Hi all, After my undergraduate, I have to say that I really did not have any background knowledge of how the industry worked in regards to medical devices. I learned a lot from part 1 and part 2 MDD. From…   Read more»

]]> 20cd8c62412f4b4413bb280df31e1243 https://medicaldevicecourses.com/activity/p/11997/ Wed, 15 May 2019 16:51:48 -0400 Hi all, Even though I still do not have experience in Validation, but I think that a type of Validation could also be Revalidation. Revalidation means repeating the original validation effort or any part of it, and includes investigative review…   Read more»

]]> 44e91fbfdc17bb43406cc9b596816b0b https://medicaldevicecourses.com/activity/p/11995/ Wed, 15 May 2019 16:51:47 -0400 HI gh56, I think that under the FDA the QSR embraces the same “umbrella” approach to the CGMP regulation that was the underpinning of the original CGMP regulation. Because the regulation must apply to so many different types of devices,…   Read more»

]]> c89ba2de38cbf7d681144aa4a2bf0ef8 https://medicaldevicecourses.com/activity/p/11993/ Wed, 15 May 2019 16:51:45 -0400 For the Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft… I believe that the IQ, OQ and PQ will be as following: IQ- The machine weaving the polyethylene fabric has been installed…   Read more»

]]> 51d3c999632953b17c90e7195b83c11d https://medicaldevicecourses.com/activity/p/11781/ Wed, 15 May 2019 16:49:41 -0400 Hi all, A DHR is a key deliverable from design controls and it is a checklist that is used during manufacturing of the device. The DHR, is created during design controls but it is not used until manufacturing of the…   Read more»

]]> e8dd5c576f7d3dfb9ce8e0853945075a https://medicaldevicecourses.com/activity/p/11767/ Wed, 15 May 2019 16:49:33 -0400 Hi all, I have not had any experience with any ECO since I still do not have experience in the medical device industry. But to my understanding. some examples in which ECO is needed could be when a modification will…   Read more»

]]> bd21931179cd43828293de14a62ff091 https://medicaldevicecourses.com/activity/p/11765/ Wed, 15 May 2019 16:49:32 -0400 It is interesting to learn that Section 522 of the Federal Food, Drug and Cosmetic Act gives the FDA the authority to require a manufacturer to conduct post-market surveillance of a class II or class III device when the device…   Read more»

]]> c84afe6d5dc625f631473c8f69ce1ca3 https://medicaldevicecourses.com/activity/p/11730/ Wed, 15 May 2019 16:49:07 -0400 Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove that each design output complies with each specification created from the DID. Design validation tests if the design conforms to user…   Read more»

]]> 4d996cb8532efd3862cfc5d269e75e45 https://medicaldevicecourses.com/activity/p/11721/ Wed, 15 May 2019 16:49:02 -0400 I believe that the DHF should be a living document that reflects the current state of the device. Keeping track of the changes (SOP’S, material, packaging, labeling..etc) and updating the DHF gives an appropriate and up-to-date information to anyone who…   Read more»

]]> bbc9a5c53d110482252e4c9a363f7ba3 https://medicaldevicecourses.com/activity/p/11715/ Wed, 15 May 2019 16:48:58 -0400 In my opinion, I think that the DHF is more useful. The reason for this is because this document is able to show a detailed and comprehensive design and development process until its release. Every change, every choice taken towards…   Read more»

]]> d9805a744f986a087aacfe6309502ee1 https://medicaldevicecourses.com/activity/p/11626/ Wed, 15 May 2019 16:48:13 -0400 I do not have any experience, but I found an article about the regulatory pathways of drug-device and device-drug combination products on the EU from the NSF. In the key points, they clearly state that it is critical to understand…   Read more»

]]> 6d5429068181749f2be8d704d017f8dc https://medicaldevicecourses.com/activity/p/11621/ Wed, 15 May 2019 16:48:10 -0400 Guideline documents are documents that generally clarifies a directives or regulation, as Dr. Simon mentioned, they are not mandatory but they are considered and accepted as the best way to follow a directive. I would have to agree with most…   Read more»

]]> 260c9cdddf7cc2b587e7c5637a70def9 https://medicaldevicecourses.com/activity/p/11619/ Wed, 15 May 2019 16:48:09 -0400 From what I learned during the lecture, I think it is easier for a medical device to be approved. The directives does not give you a “one size fits all approach” instead there are many ways,the conformity assessment route, in…   Read more»

]]> d68eeb816451fbb4700aee9f86f5bace https://medicaldevicecourses.com/activity/p/11540/ Wed, 15 May 2019 16:47:28 -0400 It also important to consider that a multi-center clinical study is more complex -in terms of coordination, quality control and data management- and very expensive in terms of personnel and resources. therefore it is essential to have an efficient central…   Read more»

]]> ca1ca76587555d336f505a153c30965e https://medicaldevicecourses.com/activity/p/11529/ Wed, 15 May 2019 16:45:44 -0400 Yes, I agree that 3D-bioprinting has become a very popular trend. I also became very interested on the subject during my senior project design. Particularly, I think the projects that wake forest are performing with 3D printing are amazing since…   Read more»

]]> 446d32c5e9fcf166f8d0d09bfe8759e9 https://medicaldevicecourses.com/activity/p/11521/ Wed, 15 May 2019 16:45:38 -0400 Hi all, gh56 I saw that you have not been able to touch upon BioMems yet. I took this class during my last undergraduate semester and I would like to give you a little information about it from what I…   Read more»

]]> c30d3cd337aafe103223cfb8683fd9b7 https://medicaldevicecourses.com/activity/p/11438/ Wed, 15 May 2019 16:44:59 -0400 The Civil Monetary Penalties Law authorizes the imposition of substantial civil money penalties against an entity that engages in activities including, but not limited to: 1) Knowingly presenting or causing to be presented, a claim for services not provided as…   Read more»

]]> 70cbeb2215a6f6b097f04a81daa2e3a8 https://medicaldevicecourses.com/activity/p/11428/ Wed, 15 May 2019 16:44:53 -0400 Another example of a kickback allegation that I found, was the $3 billion settlement agreement that GlacoSmithKline(GSK)- a British pharmaceutical and the world’s sixth pharmaceutical company- had to agree to in 2012. Besides the criminal plea agreement on off-label uses…   Read more»

]]> 5eddbc7a19f33a8f4cae64b523f60700 https://medicaldevicecourses.com/activity/p/11326/ Wed, 15 May 2019 16:43:56 -0400 I have to recognize that I expected this course to be the typical course in which you learn a great amount of theory and then you have to memorize it for the midterm and final. The fact that this course…   Read more»

]]> b3829eb398cb01a9495f5c353678fcae https://medicaldevicecourses.com/activity/p/11285/ Wed, 15 May 2019 16:43:37 -0400 I also agree that organizational structure and organizational culture do influence the success or failure of a project. Organizational structure is the foundation of how business is conducted internally and externally. It show us how operations are carried out daily…   Read more»

]]> 6f0a9cffc8ac297bba413d9cc671d536 https://medicaldevicecourses.com/activity/p/11274/ Wed, 15 May 2019 16:43:31 -0400 I would like to work in a project-based organization since I like the idea of working in a team that will only focus in one particular project that must be executed in a timely manner. Traditional organizations focus on hierarchical…   Read more»

]]> b5d7c03a99c10e7a68a193017fc3d546 https://medicaldevicecourses.com/activity/p/11271/ Wed, 15 May 2019 16:43:30 -0400 Hi hg93, I agree that a composite organization will be best suited since it allows a company to blend the functional, matrix and project-based type of organizations to help suit the company’s needs. Also,it is important to know that a…   Read more»

]]> e7519d2334cdbb030941682b0fb47875 https://medicaldevicecourses.com/activity/p/11150/ Wed, 15 May 2019 16:40:20 -0400 I do not have experience in the industry but I found that the usage of the confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are used to ensure that validation activities will yield valid…   Read more»

]]> 319460a8d40d3922641889eadad7f637 https://medicaldevicecourses.com/activity/p/11119/ Wed, 15 May 2019 16:40:04 -0400 I would like to add that FMEA is subdivided into two types: 1) Design Failure Mode and Effects Analysis (DFMEA): is an application of FMEA especially for product design. It begins at the development stage. It is a procedure used…   Read more»

]]> 559371ecc48908529726658a48ac886a https://medicaldevicecourses.com/activity/p/11117/ Wed, 15 May 2019 16:40:03 -0400 Hi Dhairya, that is actually a good question. From my point of view, these is how I would do in case of a low or high severity. 1) Hazards that fall into a low severity risk, are considered generally acceptable…   Read more»

]]> f0e9f01795f24225ad8adcb207061ee9 https://medicaldevicecourses.com/activity/p/11021/ Wed, 15 May 2019 16:39:08 -0400 I agree that meeting minutes are important, since they capture the essential information of a meeting (decisions and assigned actions). They keep team members on track by reminding them of their role in a project and clearly define what happened…   Read more»

]]> 24cda444c6d2dd8b66e2d48f69f09b5c https://medicaldevicecourses.com/activity/p/11019/ Wed, 15 May 2019 16:39:06 -0400 Even though the FDA does not have hard rules for human factors, only guidelines (as per the link given by Luisa).The FDA expects manufacturers to engage in human factors for risk management and it is very important. The human factors…   Read more»

]]> 24c94af9717ffc8154217b502fa74c20 https://medicaldevicecourses.com/activity/p/11013/ Wed, 15 May 2019 16:39:02 -0400 Now that we were able to identify most of the design transfer challenges, I believe that it will be a good idea to ask ourselves how can we avoid design transfer failures due to the challenges listed above. One of…   Read more»

]]> 044dfb3ef9e9b1a4b4fe0100db997c56 https://medicaldevicecourses.com/activity/p/11007/ Wed, 15 May 2019 16:38:59 -0400 Hi, thank you for sharing with us the steps needed for a Gantt chart, it will be really useful towards the upcoming project. I would like to add somethings to your comment. First, I was thought that if any assignments…   Read more»

]]> 7770bd3a7a13f10fb509d0436259243d https://medicaldevicecourses.com/activity/p/10521/ Wed, 15 May 2019 16:34:13 -0400 During lecture, Dr. Simon explained that clinical trials are classified as significant risk or non-significant risk. The level of risk is determined by how much harm the subject could acquire from the study. Significant risk (SR) is a study that…   Read more»

]]> 770427868f54542cc01608bf3a884fc9 https://medicaldevicecourses.com/activity/p/10509/ Wed, 15 May 2019 16:34:07 -0400 In the lecture, Dr Simon talked about two types of quality audits, the major audit performed by an outside agency, it could be the FDA or ISO and the internal audit performed by the company itself. The internal audits can…   Read more»

]]> 2777b35c0ee0609c531cea5cd793bf96 https://medicaldevicecourses.com/activity/p/10504/ Wed, 15 May 2019 16:34:04 -0400 In the lecture Dr. Simon explained that there are three basic principles: – System Approach to Management – Process Approach – Factual Approach He also explained that when you have a quality management system that is working, all three approaches…   Read more»

]]> 7ce4bc1864a2d9f6b8d799954bdf9f8a https://medicaldevicecourses.com/activity/p/10493/ Wed, 15 May 2019 16:33:59 -0400 As mentioned in the lesson, the product life cycle curve has different phases and each one contains a different set of characteristics. These phases are: – Development – Introduction – Growth – Maturity – Decline During MDD and AMDD courses…   Read more»

]]> 837adffe3d4dc1cdc6b662b50837e8ad https://medicaldevicecourses.com/activity/p/10477/ Wed, 15 May 2019 16:33:52 -0400 One of the skills that is mostly taken for granted is technical writing. As engineers, we are not only solving problems but working with new products, nevertheless, documentation of your work is also critical. It really does not matter if…   Read more»

]]> 73e4a9b4d71802ac0a816b900795c091 https://medicaldevicecourses.com/activity/p/2556/ Mon, 01 May 2017 00:15:38 -0400 I do agree with the above posts up to a certain extent. Yes the testing portion of any trial can be very time consuming and daunting but accomplishing your goals is the most rewarding. Ideally in a R&D facility, engineers draft the protocols and plans and most of the time test technicians are the ones that execute the tests which really takes a…[Read more]

]]> 0