https://medicaldevicecourses.com/members/reshamn/activity/ Activity feed for reshamn. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 826b3cc131a74224e5bb48ee4bc9f2f5 https://medicaldevicecourses.com/activity/p/15856/ Wed, 15 May 2019 19:14:38 -0400 Nowadays, most people are entering for a clinical trial that involves a cancer immunotherapy but they are at an advanced stage of the disease. Recently, there have been deaths related to this kind of trial and have put researchers on…   Read more»

]]> fb923357f1e0d3ba3135f6f4a06fa45e https://medicaldevicecourses.com/activity/p/15854/ Wed, 15 May 2019 19:14:37 -0400 CAR-T therapy is an upcoming cellular therapy to treat cancer. It has been recently shown to be successful with ALL patients. However, this wasn’t the case in July 2016 Leukemia CAR-T trials. Three adult leukemia patients died in a trial…   Read more»

]]> b1379f349523beecd39ed60629991874 https://medicaldevicecourses.com/activity/p/15853/ Wed, 15 May 2019 19:14:36 -0400 There are major differences in a SR vs. NSR studies. A SR needs to submit an IDE and must follows all regulations associated with it in 21 CFR 812. They also need that IDE approved before they can proceed with…   Read more»

]]> 5afda7723bfbaf6240616555dc593751 https://medicaldevicecourses.com/activity/p/15708/ Wed, 15 May 2019 19:13:04 -0400 An effective internal auditing takes a progressive, forward-looking mindset that helps people point out problems before they arise. By doing an audit, a company can understand how activities and processes are operating and always looking for ways to improve it….   Read more»

]]> eb3d39fa0f8a230a20df48e986245cf5 https://medicaldevicecourses.com/activity/p/15707/ Wed, 15 May 2019 19:13:04 -0400 Smaller organizations and even entrepreneurs can perform internal audits or sometimes they even have it performed by someone in an efficient and cost-effective way. This way it produces positive change and results. It can improve the overall business, the practices…   Read more»

]]> 214cd14736492487098d27f150263d00 https://medicaldevicecourses.com/activity/p/15706/ Wed, 15 May 2019 19:13:03 -0400 There are both pro and cons to GMP. The major pro is that it assures that the identity, quality and the purity of the product is legitimate and that it requires manufacturers by abide by strongly. But the downside of…   Read more»

]]> 1bacbe6e843e2134aca9c8b24f47bedf https://medicaldevicecourses.com/activity/p/15666/ Wed, 15 May 2019 19:12:41 -0400 A CAPA process that I was a part of during my exposure in the IT industry. Although, the term CAPA wasn’t used but the process was similar. There was a defect in running our energy scripts in the software called…   Read more»

]]> 0fcc13e7fa4c9feb0905e8d46392ac04 https://medicaldevicecourses.com/activity/p/15665/ Wed, 15 May 2019 19:12:41 -0400 I would also like to touch upon the importance of CAPA. CAPA is extremely essential in the manufacturing area. It gives the early benefit of identifying current and potential issues in a product before it goes into production or as…   Read more»

]]> 9ff7a8def627dd552ef32f25257d79ea https://medicaldevicecourses.com/activity/p/15664/ Wed, 15 May 2019 19:12:40 -0400 Sometimes, presenting numbers isn’t the effective way to communicate the need for more resources, for instance budget. By taking the focus away from numbers, one can present how the objective meets the company goals. You can even sometimes link it…   Read more»

]]> d96b482390533aae53b7d9f023611b4e https://medicaldevicecourses.com/activity/p/15476/ Wed, 15 May 2019 19:06:45 -0400 While all are important to be a successful product manager, there was another aspect that I came across during my research. One of the most important characteristics of a great PM is their relationship management skills. This is a very…   Read more»

]]> 34ce08dff00f8e1a2b15c12d89d06b55 https://medicaldevicecourses.com/activity/p/15474/ Wed, 15 May 2019 19:06:44 -0400 If the company is high in the tech arena, then their products can out date in relatively short amount of period. Sometimes, components for older products need to comply with new standards or requirements. If the sales for that product…   Read more»

]]> 578d219a604fef5e1052ec3078033d7a https://medicaldevicecourses.com/activity/p/15471/ Wed, 15 May 2019 19:06:42 -0400 Along with the posts above, assuming there is funding available and a separate group to drive the innovation, there is always the problem the innovation being brought up in a wrong time. It could be a novel and achievable idea…   Read more»

]]> a6e2f6509fd9680f6c1595a098182b2e https://medicaldevicecourses.com/activity/p/15217/ Wed, 15 May 2019 19:04:03 -0400 Thanks for bringing up a great point. As an undergraduate, I was required to take a technical writing course but sadly enough, that course was very similar to any other Humanities course. The closest exposure to technical writing was provided…   Read more»

]]> 95e787b5a278cdec66dcc5768d07d934 https://medicaldevicecourses.com/activity/p/15216/ Wed, 15 May 2019 19:04:03 -0400 In agreement with the post above that it is more beneficial to be proactive than reactive. In the reactive approach, a root cause analysis is usually performed to answer ‘why’ a problem exists. However, with the proactive approach, different kinds…   Read more»

]]> bbc4037549ba8bc156e34d04ac787055 https://medicaldevicecourses.com/activity/p/15214/ Wed, 15 May 2019 19:04:02 -0400 I agree with the post above that it can be tedious and time consuming to re-validate all processes. However, the process is very critical to make sure that the equipment is producing the same results in each location. If the…   Read more»

]]> 2619d4153e5fcd48ea6d8e60405ed25d https://medicaldevicecourses.com/activity/p/14924/ Wed, 15 May 2019 19:01:24 -0400 I worked in the software development area. Our company would call it the Engineering Change Order for Code Change. There were many change orders depending on whether it was an addition to the code, or enhancement. Sometimes, it would be…   Read more»

]]> 5892e23ac0c35141326d30423ff71523 https://medicaldevicecourses.com/activity/p/14923/ Wed, 15 May 2019 19:01:24 -0400 The change process is really when someone identifies an issue that may need to be addressed. In agreement to the post above, there is a cost factor added to any kind of ECO. Therefore, an ECO is reviewed very carefully…   Read more»

]]> fbce6e5032d46604ad82f8909b3552a9 https://medicaldevicecourses.com/activity/p/14922/ Wed, 15 May 2019 19:01:23 -0400 SOP is basically a step by step instructions document compiled so that the workers can carry out a complex routine efficiently. I definitely think the SOP’s should be written during research phase. In fact, I used to intern at a…   Read more»

]]> 5e983681c2b61bddbc0ede891edf01df https://medicaldevicecourses.com/activity/p/14733/ Wed, 15 May 2019 18:59:36 -0400 A follow-up question from Dr. Simon’s post: As I mentioned earlier, once the DHF is sealed any ongoing changes should be added to the DMR seems more logical to me. For those of you who are currently working in the…   Read more»

]]> f92b3f68b1aa4c719a8a92050a508a59 https://medicaldevicecourses.com/activity/p/14726/ Wed, 15 May 2019 18:59:32 -0400 The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls documentation and therefore it is a requirement by the FDA for the 510k submission….   Read more»

]]> 5f9bde2035a352d971490833183e0ba3 https://medicaldevicecourses.com/activity/p/14720/ Wed, 15 May 2019 18:59:29 -0400 In my opinion, the first thought where the DHF is sealed and any updates after the design transfer are added to the DMR seems more logical. Technically, DHF is put together initially when the product was being planned, researched and…   Read more»

]]> 9798d3d9b9673f5ac103be2b077985fe https://medicaldevicecourses.com/activity/p/14661/ Wed, 15 May 2019 18:58:57 -0400 I was able to find one example of where the classification of a device was different in the EU vs the US. Contraceptives such as a female condom is classified as a Class III device in the US where as…   Read more»

]]> 2576179d69337be6d9d4be2b91d2d17f https://medicaldevicecourses.com/activity/p/14660/ Wed, 15 May 2019 18:58:56 -0400 Another difference between 510k and a technical file is the submission of a clinical evaluation report. All devices with a CE marking must have a clinical evaluation report. It is an essential requirement in Annex I of the Medical Device…   Read more»

]]> 365cfb4b1afd8b6867d6c7bfe1748be2 https://medicaldevicecourses.com/activity/p/14659/ Wed, 15 May 2019 18:58:56 -0400 One of the main differences between 510k and a technical file is the risk management file. Although, ISO 14971 requires a risk management file to be submitted regardless of where the medical device is being sold. The US FDA doesn’t…   Read more»

]]> 32e519270ed21ba0abd27dc72d6c0f42 https://medicaldevicecourses.com/activity/p/14508/ Wed, 15 May 2019 18:57:31 -0400 I used to work for an IT firm where I was assigned to a client that used to focus on VR for physical rehabilitation. Earlier, that company was hiring their own technology experts/consultants to provide the technology. Over the course,…   Read more»

]]> 750b2bc7d86958c34e976ee279980b4d https://medicaldevicecourses.com/activity/p/14507/ Wed, 15 May 2019 18:57:31 -0400 I have not had an experience working with PMOA for a combination device yet. Upon some researching, I have found out that PMOA is very critical when establishing a product’s regulatory and product development framework. Technically speaking when we need…   Read more»

]]> 70c53564c406c420c0ab032b14a01f80 https://medicaldevicecourses.com/activity/p/14453/ Wed, 15 May 2019 18:57:07 -0400 In my personal experience, I also had to sign a non-compete during on boarding which restricts me from working at certain companies. I have witnessed cases where my client wanted to hire an employee where we had a non-compete with….   Read more»

]]> 7f5c99c5a7d53ae6dc020bef232eb9ec https://medicaldevicecourses.com/activity/p/14447/ Wed, 15 May 2019 18:57:03 -0400 NDA usually excludes the information that is publicly available or information that was already made available to the recipient prior to its disclosure. It also excludes information which was obtained by a third party which may or may not be…   Read more»

]]> ddc8ef5e828738af785efa6cd99c5828 https://medicaldevicecourses.com/activity/p/14329/ Wed, 15 May 2019 18:55:11 -0400 Although, the team members enjoy working with people who they have a good rapport with. However, in my experience roles are allocated in a team based on a team member’s expertise and background. There are always few subject matter experts…   Read more»

]]> 93933e382ed7cbc0eafa243225735010 https://medicaldevicecourses.com/activity/p/14326/ Wed, 15 May 2019 18:55:10 -0400 I too have been a part of a Matrix organization. I would agree with the posts above that it does get confusing sometimes. I had a functional manager and a reporting manager for the same project. However, the things were…   Read more»

]]> 49d5152d7b05472d00328aeb0a6356e3 https://medicaldevicecourses.com/activity/p/14325/ Wed, 15 May 2019 18:55:09 -0400 Delegation is one of the key differences between upper and middle management. Since a senior manager spends most of his energy on creating effective strategies. He has to be able to delegate decision making on non-strategic issues. In order for…   Read more»

]]> ff8cadd6617a0282f1109e4a9b97a032 https://medicaldevicecourses.com/activity/p/14005/ Wed, 15 May 2019 17:10:21 -0400 Software can be an essential component of the medical device, whether it is designing a new product or improving the functionality of an existing one. When it comes to the software in medical devices, one seemingly minor change can have…   Read more»

]]> bd48ba05557b8ecdb468c9bbaf529aca https://medicaldevicecourses.com/activity/p/14004/ Wed, 15 May 2019 17:10:20 -0400 There are several factors that must be considered when determining the appropriate sample size including risks associated with the product, costs associated with producing the product, and costs associated with inspection, measuring, and testing. It is very important to consider…   Read more»

]]> 35bd1b2ecc1f6cac1fa545e0c807b10f https://medicaldevicecourses.com/activity/p/14003/ Wed, 15 May 2019 17:10:19 -0400 Feedback plays a critical role in the design process. In order to make sure the review meetings go smoothly, the attitude of the team needs to be in order. The meetings should not devolve into firing lines where the team…   Read more»

]]> b2f9c9221a14653862b5738ef94bbc91 https://medicaldevicecourses.com/activity/p/13947/ Wed, 15 May 2019 17:09:46 -0400 A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements….   Read more»

]]> 8b2fd7f82d6fde22f4d829bfea9d21c9 https://medicaldevicecourses.com/activity/p/13944/ Wed, 15 May 2019 17:09:44 -0400 Adding to the previous posts, the format of the Design Verification is equally important. Although, format of the DV is not as important as the quality of information it contains. However, if the data does not flow correctly in the…   Read more»

]]> 6ed50bc2cadc65920f0c237ba655b3e2 https://medicaldevicecourses.com/activity/p/13942/ Wed, 15 May 2019 17:09:42 -0400 Multiligamentous Ankle Supports (L1906) A multiligamentous ankle support provides control of the ankle joint between the medial and lateral malleoli while allowing for dorsiflexion and plantar flexion. Medicare announced an additional verification for the ankle supports to 1. Include a…   Read more»

]]> c19d35908b086d0afc956f515119a919 https://medicaldevicecourses.com/activity/p/13823/ Wed, 15 May 2019 17:08:32 -0400 An important tip in creating a Gantt Chart is defining a critical path. It is a method of looking at all of the activities in the Gantt chart, considering the timing and dependent relationships of each, and calculating the longest…   Read more»

]]> fd335300a89d90bcce1b50d1343c3d02 https://medicaldevicecourses.com/activity/p/13822/ Wed, 15 May 2019 17:08:31 -0400 One thing to point out about a DHF is that every team member who is involved in the planning/development of a particular medical device should have access to the DHF. Sometimes, new recruits might not be given access just to…   Read more»

]]> cb6ce42cefb11659c90a5afeda435d83 https://medicaldevicecourses.com/activity/p/13821/ Wed, 15 May 2019 17:08:31 -0400 Defining user needs are extremely important as in the future you definitely need to demonstrate that the product you develop addresses the User Needs you define. FDA doesn’t really define User Needs in the 820.30 regulations per se. User Needs…   Read more»

]]> 13433f0c8c71ef7ace92af3c99702f50 https://medicaldevicecourses.com/activity/p/13623/ Wed, 15 May 2019 17:06:38 -0400 The most obvious advantage of a clinical trial is that you have access to a new treatment that you wouldn’t have otherwise. People are likely to go through regular testing which is in most cases very beneficial to the patient….   Read more»

]]> a3c1e15460eb3c08e7ee56bf208576b2 https://medicaldevicecourses.com/activity/p/13617/ Wed, 15 May 2019 17:06:33 -0400 I would opt for the Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes of the clinical trial to make sure that they comply with certain guidelines, known as the good clinical practice (GCP). They make sure the…   Read more»

]]> f450cba9c61692e461fa41e77dd95a65 https://medicaldevicecourses.com/activity/p/13613/ Wed, 15 May 2019 17:06:30 -0400 From a little bit of research, it seems very apparent that prior experience is required for applying for a role in clinical research. I agree with amandaally1029 thoughts that it varies for different roles. However, a sponsor actually requires the…   Read more»

]]> 8c61943ef68e6de678929db1c3a3da95 https://medicaldevicecourses.com/activity/p/13482/ Wed, 15 May 2019 17:05:15 -0400 “EI refers to our ability to understand moods, behaviors and impulses, and control them to match a particular situation.” This concept is extremely important to understand as there are very few companies who understand the emotion of their buyer. It…   Read more»

]]> 25ff88047a43273e31b62b787d58ec92 https://medicaldevicecourses.com/activity/p/13480/ Wed, 15 May 2019 17:05:14 -0400 Stryker Mission: “Together with our customers, we are driven to make healthcare better” Vision: They do not have a clear vision statement however, in the company description is states, “Stryker is one of the world’s leading medical technology companies and,…   Read more»

]]> 0622fe5e1771e3ee3eee2c5e300e6627 https://medicaldevicecourses.com/activity/p/13472/ Wed, 15 May 2019 17:05:10 -0400 The most popular way of marketing these days is using social media. There is an increasing use of social media everyday. Popular social media channels include Facebook, Twitter, Instagram, Pinterest, Reddit, LinkedIn, Google Plus and Snapchat are all different unique…   Read more»

]]> 0c88f89b6b3e96156e49e9a83eff456b https://medicaldevicecourses.com/activity/p/13373/ Wed, 15 May 2019 17:04:23 -0400 A tech startup can incorporate in many different forms, but an LLC, C-Corp, or S-Corp are most common. Each form has its pros and cons and your choice can therefore help or hurt you as your company grows. For this…   Read more»

]]> 3e8178f6d1098f9880314b3544e1829a https://medicaldevicecourses.com/activity/p/13372/ Wed, 15 May 2019 17:04:22 -0400 Apple financial findings as of July 2017(Quarterly) are as follows: Gross Profit Margin: 38.51% Net Profit Margin: 19.20% Net Income: 46.65B ROE: 35.68% ROI: 18.39% ROA: 14% The gross profit margin is quite high and has been improving with every…   Read more»

]]> f117e219b07acbfea0f3012c754284c7 https://medicaldevicecourses.com/activity/p/13242/ Wed, 15 May 2019 17:03:11 -0400 I worked for a software company where part of my job was to test the upcoming applications and softwares that would be used by the financial tower of my client. There are many tools depending on the type of application…   Read more»

]]> 950f799a04993b5040dbdac5d8a2a1c6 https://medicaldevicecourses.com/activity/p/13241/ Wed, 15 May 2019 17:03:11 -0400 Based on my past work experience, I have repeatedly encountered a hesitation/resistance to any kind of new processes from the quality department. If an engineer is coming up with a new and innovative approach to tackle a problem, the quality…   Read more»

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