https://medicaldevicecourses.com/members/vnd4/activity/ Activity feed for Viraj D. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e0c5687b67a9be89c25ac92f475fc35d https://medicaldevicecourses.com/activity/p/12548/ Wed, 15 May 2019 16:57:02 -0400 As others have mentioned, if adverse side effects are observed after the product was used/administered by a patient during a clinical trial, it is most likely paused until effects go away and a solution is found as to what is…   Read more»

]]> bfc03ffe423447f82cd22f7d6a0cd6e0 https://medicaldevicecourses.com/activity/p/12547/ Wed, 15 May 2019 16:57:02 -0400 With my current experience working in the industry, taking part in clinical trials can be a very daunting task with quite a lot of paperwork. Finding a statistical significance can vary from 500 patients to even a couple thousand, so…   Read more»

]]> 31157059e2d343c4bfef734f3702edef https://medicaldevicecourses.com/activity/p/12546/ Wed, 15 May 2019 16:57:01 -0400 These simulations definitely helped understand the topics we learned during class. I believe the last simulation we are currently working on is the most realistic where it can apply to a real life experience. While working in the industry, something…   Read more»

]]> 04c746dc9804c919d3d7a74d19255f4c https://medicaldevicecourses.com/activity/p/12475/ Wed, 15 May 2019 16:56:22 -0400 As the person above provided examples, an easier way to observe the difference between significant risk medical devices and non significant risk devices is looking at the classification which is defined by the FDA. If a device is labeled as…   Read more»

]]> d3522c0ec8765aac6afe84beaed7c949 https://medicaldevicecourses.com/activity/p/12457/ Wed, 15 May 2019 16:56:13 -0400 If a CRO is not able to deliver the expected results I am sure there is language within the contract specifying this possible outcome and steps to take to get a proper return on their money and resources. Usually, strong…   Read more»

]]> 54b2c174530e678ee91c2d70ab9bb6b7 https://medicaldevicecourses.com/activity/p/12380/ Wed, 15 May 2019 16:55:28 -0400 From my experience with a CAPA usually an ER is filled out with the non-conformity which initiates the CAPA process. An example that occurred in my company was a minor one but there was a labeling issue due to a…   Read more»

]]> dd0dc8f7a98ba97d9cfb5a31f15ad0a2 https://medicaldevicecourses.com/activity/p/12379/ Wed, 15 May 2019 16:55:28 -0400 As mentioned above, usually corrections and CAPAs go hand in hand. Corrections are immediately done to eliminate the non-conformity in real time. While CAPA’s, are steps taken to find the root cause of the non-conformity, document it and the necessary…   Read more»

]]> d54dda812ab6c8dbc3e13c543758b743 https://medicaldevicecourses.com/activity/p/12378/ Wed, 15 May 2019 16:55:27 -0400 From my experience with dealing with internal audits, the purpose of it is to prepare the company from a major audit that would occur by the FDA. It allows the company to do a thorough search to find potential holes…   Read more»

]]> 1d311b258136895687fe941b3f2d33f7 https://medicaldevicecourses.com/activity/p/12312/ Wed, 15 May 2019 16:54:46 -0400 I believe in general as a company starts to focus on new processes or focuses on a new project there will always be a learning curve. However, for start up companies due to their size, for the most part you…   Read more»

]]> cfb2ba53db85986ccf586fa57de3a436 https://medicaldevicecourses.com/activity/p/12311/ Wed, 15 May 2019 16:54:45 -0400 As the others have mentioned, if there were no GMPs I believe most companies would not follow the guidelines set forth for good manufacturing processes mainly due to the money. Focusing on following standards makes for extra resources and time,…   Read more»

]]> 2c46bef561c572930d25520222b0d0ef https://medicaldevicecourses.com/activity/p/12248/ Wed, 15 May 2019 16:54:10 -0400 As others have mentioned, the development phase is the most expensive due to the time and effort from the design generation stage. Additionally, during the development phase, any pre-clinicial trials or clinical trials may cost up to more than millions…   Read more»

]]> 683b7eed276539eee845c21e498b5a7a https://medicaldevicecourses.com/activity/p/12247/ Wed, 15 May 2019 16:54:10 -0400 I believe the product manager has many roles which include, identifying profitable opportunities that meet market needs, launch products into the market, oversee products already in the market, and wind down products that no longer meet the market needs. A…   Read more»

]]> 2fab55dc9abcc70967287b25805dc0cc https://medicaldevicecourses.com/activity/p/12246/ Wed, 15 May 2019 16:54:09 -0400 I agree with the comments above where a successful team leader should have good interpersonal skills. It is essential for the leader to additionally have knowledge of the market place, costs of competitors and understand the customer you are trying…   Read more»

]]> 93a0924e3139c4111d55b0a28f094bda https://medicaldevicecourses.com/activity/p/12174/ Wed, 15 May 2019 16:53:30 -0400 In the Discovery and Innovation phase of the Product Life cycle phase, it is important to understand the customer. Analyze and research the customers needs, if there is something that could fulfill a void or be done easier and a…   Read more»

]]> 48acb460427c372ae351a0c82768d1b8 https://medicaldevicecourses.com/activity/p/12173/ Wed, 15 May 2019 16:53:29 -0400 As others have mentioned the main reason a product gets “killed” midway through the research phase is simply due to the money. If the research and development of the device is taking too long and upper management is not seeing…   Read more»

]]> 4c11d44b9436cedbb9200680dcdc15c0 https://medicaldevicecourses.com/activity/p/12172/ Wed, 15 May 2019 16:53:29 -0400 I don’t have experience with dealing with a launched product that failed, but the most recent example of a product having to be pulled from the market are the Samsung Note 7s. This massive recall was due to the fact…   Read more»

]]> 646b78d330a82d26638a15c7444dc0d6 https://medicaldevicecourses.com/activity/p/12054/ Wed, 15 May 2019 16:52:24 -0400 The purpose of the SOP is to create a step by step procedure to help workers carry out routine operations. So, I don’t believe that there is any issue with having too much detail. The purpose of this document is…   Read more»

]]> 36201ccce8f96e019caeebdf59f37e0f https://medicaldevicecourses.com/activity/p/12052/ Wed, 15 May 2019 16:52:23 -0400 I believe SOPs are required for the research phase, because there should be steps on the thought process of you reaching that idea, exploring the different possibilities, creating different designs, as well as other things. The DHF includes files from…   Read more»

]]> 495363f27e2fe15d512d3f5f7edc726d https://medicaldevicecourses.com/activity/p/12051/ Wed, 15 May 2019 16:52:23 -0400 As with each process validation, there should be an SOP for which any employee dealing with the validation should be trained to. Additionally, the validation depends on what type of medical device your company is producing, and it would depend…   Read more»

]]> a309a071bcf54310cf06350dbd3fef79 https://medicaldevicecourses.com/activity/p/12049/ Wed, 15 May 2019 16:52:22 -0400 I don’t believe there is really an expiration date for a validation. Each installation qualification process gets updated every year or so. Due to this, it accounts for any changes that may occur in terms of technology, new specifications, and…   Read more»

]]> 9487d31e061b7051492509d3fd8f54f8 https://medicaldevicecourses.com/activity/p/12048/ Wed, 15 May 2019 16:52:21 -0400 Due to working in the industry I was familiar with the FDA requirements and regulations, but this class certainly helped in providing background and information on how the regulations for the EU works. With the EU they have 3 major…   Read more»

]]> cd9b8fdede271bfabeaaacee15ce109e https://medicaldevicecourses.com/activity/p/12046/ Wed, 15 May 2019 16:52:20 -0400 Along with having multiple vendors, as a Manager you should also account for the risks that a potential vendor may run into issues. With this you schedule and plan dates for either an early finish, which is the date for…   Read more»

]]> 9f888bad707852f9f139df0b2f42ae3f https://medicaldevicecourses.com/activity/p/11956/ Wed, 15 May 2019 16:51:26 -0400 If equipment gets moved from one location to another, I do agree that a revalidation would have to occur, but for only certain aspects. There are many validation processes, so I don’t believe a full re-validation would have to occur….   Read more»

]]> a6a43e6a784693213a0814d84ae92870 https://medicaldevicecourses.com/activity/p/11954/ Wed, 15 May 2019 16:51:25 -0400 For the antibiotic releasing hip stem manufacturing line which creates an artificial hip with an antibiotic coating on the surface, I believe the IQ involved in this manufacturing line would be written procedures on how to use the equipment to…   Read more»

]]> be84d2342626d3dac1ad4b76652e38b4 https://medicaldevicecourses.com/activity/p/11788/ Wed, 15 May 2019 16:49:45 -0400 ECO’s are not very commonly used once the device is on market due to the main reason of money. However, recently at my company the on market device which is used globally and in specifically in China, the main board…   Read more»

]]> 8059ce1e12f3287e70874d76357597f2 https://medicaldevicecourses.com/activity/p/11786/ Wed, 15 May 2019 16:49:44 -0400 Per personal experience to track the medical devices while it is on market, the company I work at has a technical support team that answers any immediate questions or complaints a user may have. Hopefully most of the time the…   Read more»

]]> c3a0f9289544b3a3a8beee4099f0ed18 https://medicaldevicecourses.com/activity/p/11785/ Wed, 15 May 2019 16:49:43 -0400 To answer your question of when do you need to generate a DHF vs. DHR is that the DHF is created during the first planning session of the developing the device. This includes every document from the inception of the…   Read more»

]]> 0ae45b80c214ac090f97a27ac64170f6 https://medicaldevicecourses.com/activity/p/11679/ Wed, 15 May 2019 16:48:40 -0400 Definitely great points made, but with the DHF even though it contains all revisions, changes, and mistakes from the devices inception it will also contain design input requirements and user requirement specifications. This essentially gives an overview of the device…   Read more»

]]> bb6396a360192eef064be48cf6a99d18 https://medicaldevicecourses.com/activity/p/11664/ Wed, 15 May 2019 16:48:33 -0400 By process, I am assuming you mean any standard operating procedures and policies created by the Quality department. These processes are considered higher level documents, which explain how to perform a Design Validation Process, Product Risk Management Plan, Design Verification…   Read more»

]]> 1d4dc4374cd58f1f71db3471131a2196 https://medicaldevicecourses.com/activity/p/11648/ Wed, 15 May 2019 16:48:24 -0400 The school of thought that appeals to me the most, is the process where once the design transfer occurs the DHF is sealed. I say this mainly because I only have experience doing it this way. After the design transfer,…   Read more»

]]> 068babddfff2390bf6900608cd48f9f9 https://medicaldevicecourses.com/activity/p/11642/ Wed, 15 May 2019 16:48:21 -0400 I believe the main difference is that the EU focuses on the risk as Dr. Simon mentioned in his lecture. Each classification based on the medical device directive is based on risk, so to an extent, the EU is taking…   Read more»

]]> 1ea5712394236100737a549d1d68d1ea https://medicaldevicecourses.com/activity/p/11591/ Wed, 15 May 2019 16:47:56 -0400 I do not have experience with filing for combination products within the EU but I believe what helps in distinguishing if your product falls under the MDD 93/42/EEC or the MDP 2001/83/EEC is to choose a Notified Body with the…   Read more»

]]> 65cdcb51b08d2be75ebb8dc782a90a6a https://medicaldevicecourses.com/activity/p/11590/ Wed, 15 May 2019 16:47:55 -0400 Per my personal experience, the current company I worked for used the same approach in receiving approval by the EU and obtaining the CE Mark before getting FDA approval. In general I believe it was easier because the device that…   Read more»

]]> 3f57be8b762c2abef969ab7c0c276fc7 https://medicaldevicecourses.com/activity/p/11573/ Wed, 15 May 2019 16:47:47 -0400 Outlined by the FDA if it is difficult or unclear on determining the primary mode of action for the combination product, you can file a Request For Designation (RFD), which is outlined in 21 CFR Part 3, and the specific…   Read more»

]]> 0686b488fd079f9e4365fb6e92aff02f https://medicaldevicecourses.com/activity/p/11572/ Wed, 15 May 2019 16:47:46 -0400 In dealing with contracts, one issue that sometimes comes up especially when working with a company that is overseas is pay of currency. Contracts were written the amount that they would be paid in US dollars, but sometimes the company…   Read more»

]]> 841f1aede9e91afb8a6971a73738207e https://medicaldevicecourses.com/activity/p/11465/ Wed, 15 May 2019 16:45:11 -0400 I currently work in Industry, and with the new age of technology the point of care diagnostic device that I work on added a new capability of connecting wirelessly with being able to transmit collected data up to a cloud….   Read more»

]]> b0a623219ffd2daadf369fc767636470 https://medicaldevicecourses.com/activity/p/11349/ Wed, 15 May 2019 16:44:07 -0400 I believe the medical device development course was a great way to give exposure to the industry side of things. I think classes similar to this give the best real life experience in the work field because they are actually…   Read more»

]]> 58188996591005ac25933f052a4e3455 https://medicaldevicecourses.com/activity/p/11348/ Wed, 15 May 2019 16:44:07 -0400 The difference is that a patent is a federal document proving ownership of an idea, and an NDA is simply a contract between two people. So in other words NDA’s only recognize the signatures on the contract, whereas patents provide…   Read more»

]]> 82945945efb1000ceec434a634c106c6 https://medicaldevicecourses.com/activity/p/11347/ Wed, 15 May 2019 16:44:06 -0400 As others have mentioned a written contract is a legal binding document, where you have signed pen to paper. Certain clauses allows to you to break from it, but if you there are any agreements in the contract that you…   Read more»

]]> 86d148b6524ef505fa5127d5b05bb693 https://medicaldevicecourses.com/activity/p/11213/ Wed, 15 May 2019 16:42:59 -0400 In a company setting, working with someone you have a good relationship with always does helps tasks move faster to get things done, but I do not believe you should look away at an individual who may be more competent…   Read more»

]]> ba32a28787a7db909a3648002c4f1280 https://medicaldevicecourses.com/activity/p/11212/ Wed, 15 May 2019 16:42:59 -0400 I believe, if first starting up a company, such as a start up and do not want to have the corporate feel to the company, I believe an organic organization structure makes the most sense to start off. You have…   Read more»

]]> f8a6d3710be840ec090702326c12e25b https://medicaldevicecourses.com/activity/p/11194/ Wed, 15 May 2019 16:40:52 -0400 In my current company, the organization type is a mix between functional and a project based organization. There are individual departments ranging from Hardware Eng, Quality, Software Eng, Systems Eng, Marketing, and Manufacturing. There certainly are silos, but for those…   Read more»

]]> ea60042f6b2247583f753911f0bfd403 https://medicaldevicecourses.com/activity/p/11102/ Wed, 15 May 2019 16:39:55 -0400 In the current company I work at, we identify risks through a PHMM or Product Hazard and Mitigation Matrix. In these meetings you have directors from R&D, Quality, Manufacturing, and the Medical director discuss the potential applicable product risk management…   Read more»

]]> fab0b6b5ed0f160782b3cbb03dea5bf1 https://medicaldevicecourses.com/activity/p/11088/ Wed, 15 May 2019 16:39:48 -0400 Some other tools that I have seen used in risk management is root cause analysis. This allows us to pinpoint the factor or cause of the failure to help resolve and analyze how to stop it, how to prevent it…   Read more»

]]> 90e7bf234c330690b5bc11c7be478892 https://medicaldevicecourses.com/activity/p/10955/ Wed, 15 May 2019 16:38:16 -0400 Design review meetings consist of many things. They review updates and changes that may be necessary and make a decision on said decision. Usually in these meetings you have a representative from each department, such as Quality, Regulatory, Marketing, and…   Read more»

]]> 5b1b66c2368977dfd6e65e07aac30bc0 https://medicaldevicecourses.com/activity/p/10954/ Wed, 15 May 2019 16:38:16 -0400 I actually just wrote and performed both verification procedures as well as validations for the current company I work at. FDA does not mandate a specific way verifications are performed, they just mandate in their 510k or PMA submissions that…   Read more»

]]> bdc936ba51e279d0a1d48b0234084719 https://medicaldevicecourses.com/activity/p/10953/ Wed, 15 May 2019 16:38:15 -0400 Meeting minutes are a very important part of the design change process of the device and development as well. It depends what stage you are in the the medical device development cycle, that certainly dictates the importance of the meeting…   Read more»

]]> b710c1298bec06bca5d8d4a7a7c80cac https://medicaldevicecourses.com/activity/p/10834/ Wed, 15 May 2019 16:37:00 -0400 I agree as well with the comment above, that if to choose a certain aspect that is important in the design development plan, the scope management plan is quite important. This details the ideas of the medical device and each…   Read more»

]]> 754b2ce92f68805e70be6889c1f8c2c1 https://medicaldevicecourses.com/activity/p/10833/ Wed, 15 May 2019 16:37:00 -0400 The reason design controls fails is because either procedures are not followed or the procedures themselves are poorly written, and the planning of every aspect of the device and documentation is poor. However, in a medical device industry that rarely…   Read more»

]]> e1f20a2ada41780ff13dbb45c07dd8c6 https://medicaldevicecourses.com/activity/p/10832/ Wed, 15 May 2019 16:36:59 -0400 To add to the previous response, design verifications and design validations are very similar however, design verifications verify the design inputs and outputs. Design validations check that the user required specifications are met, and the that the medical device is…   Read more»

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