https://medicaldevicecourses.com/members/sahitya-sadineni/activity/ Activity feed for sahitya.sadineni. Fri, 24 Apr 2026 17:41:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d89d6ee39e53486f93dbfe57bc59c54e https://medicaldevicecourses.com/activity/p/16048/ Wed, 15 May 2019 19:16:32 -0400 I have learnt to work together and think outside the box. You can not just work with the information you have but also do research and see what else you can come up with. You need to know its not…   Read more»

]]> cfc119968c0324fd002e52d73125a9cb https://medicaldevicecourses.com/activity/p/16047/ Wed, 15 May 2019 19:16:32 -0400 It was interesting working with people you have never met before. This is what happens in the real world job, you are collaborating with people you don’t know. I have learned that you need to listen to other people’s ideas…   Read more»

]]> 815cd169f891b6ec40e1580e1ad81e2e https://medicaldevicecourses.com/activity/p/15930/ Wed, 15 May 2019 19:15:21 -0400 My motivation is the people around me. If I know that I will be able to have fun and be able to talk to them freely, it helps me do the work and enjoy it also. I remember my first…   Read more»

]]> 634a6eed99dec80de23e9520a0b4a3a4 https://medicaldevicecourses.com/activity/p/15929/ Wed, 15 May 2019 19:15:21 -0400 Most people want to work because they want some sort of challenge but of course, they do it for the money also. But what drives people to go to work every morning is the environment they are in. The co…   Read more»

]]> 74924f3a742b37a30fe6d708463ffbc7 https://medicaldevicecourses.com/activity/p/15924/ Wed, 15 May 2019 19:15:18 -0400 People leave work most of the times because they have a better opportunity waiting for them. But the reason they start looking for a new job is because they are getting bored at their current job and aren’t challenged enough….   Read more»

]]> 352cc562a12ca2f06466a7b055b2a055 https://medicaldevicecourses.com/activity/p/15801/ Wed, 15 May 2019 19:14:01 -0400 HR plays a huge role in any company. They go through the whole process of filtering candidates for the job positions, have many rounds of interviews with them and the hiring manager, and finally process the paperwork for everything. Finding…   Read more»

]]> 29f04004549f3414bb683cda11afdb27 https://medicaldevicecourses.com/activity/p/15786/ Wed, 15 May 2019 19:13:52 -0400 Two terms that have many interpretations because of the multiple definitions for the words assurance and control. One definition of quality assurance is: all the planned and systematic activities implemented within the quality system that can be demonstrated to provide…   Read more»

]]> 6c726b75946b25ed26b4129d74aff52b https://medicaldevicecourses.com/activity/p/15561/ Wed, 15 May 2019 19:07:40 -0400 With failures in projects, it should be kept in mind that they will happen. We need to proceed without panicking and try to overcome the failures. In projects, they are always a setback in deadlines but that is why in…   Read more»

]]> f679213e9bb60efc548954743f89f667 https://medicaldevicecourses.com/activity/p/15560/ Wed, 15 May 2019 19:07:39 -0400 Design transfers are successful with communication and status meetings. These meetings should be used to keep everyone updated and also look at additional documents. Also a key factor would be to address any additional customer needs that were updated. Any…   Read more»

]]> a5987f6b67288c2d754a026fb0a86006 https://medicaldevicecourses.com/activity/p/15558/ Wed, 15 May 2019 19:07:38 -0400 For a change request, it is also very important to look at the other documents that would be affects such as the SOP’s. For instance, if the name of the product is being changed, you need to have a change…   Read more»

]]> d956877e3aaf75377e4062df50f339b8 https://medicaldevicecourses.com/activity/p/15438/ Wed, 15 May 2019 19:06:23 -0400 When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include…   Read more»

]]> 0b551f5fb14ea445fa9cef1e39492306 https://medicaldevicecourses.com/activity/p/15414/ Wed, 15 May 2019 19:06:04 -0400 When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include…   Read more»

]]> c243ec8c7c9d7375bca44e1ad6485d7c https://medicaldevicecourses.com/activity/p/15413/ Wed, 15 May 2019 19:06:03 -0400 Verification is a theoretical exercise designed to make sure that no requirements are missed in the design, whereas validation is a practical exercise that ensures that the product, as built, will function to meet the requirements.The purpose of Design Validation…   Read more»

]]> bb9af9bb8d7339e8adc7ff29b9fc194d https://medicaldevicecourses.com/activity/p/15245/ Wed, 15 May 2019 19:04:23 -0400 ECO gives the chance for a team to see a mistake and have a chance to correct that mistake and document the change. This allows for teams to document changes carefully and also make sure the same mistakes do not…   Read more»

]]> d9af5de51e78e87605ceb72750d37a87 https://medicaldevicecourses.com/activity/p/15210/ Wed, 15 May 2019 19:04:00 -0400 One of the most famous Six Sigma tools called DMAIC (Define, Measure, Analyze, Improve and Control) offers a structured approach for resolving organizational management-related issues. DMAIC can be understood as a troubleshooting-cum-improvement focused approach utility tool. However, relying exclusively on…   Read more»

]]> d3569fa37b7233a9435229706baa1b93 https://medicaldevicecourses.com/activity/p/15208/ Wed, 15 May 2019 19:03:59 -0400 Gantt charts are a valuable tool to have in project planning arsenal. Managers use them to perform a variety of project management (PM) functions, including: -Visualize the critical path. -Set baselines for project scope, budget and schedule—three metrics that are…   Read more»

]]> 22cd654a7effc55dfd84d0926d8e51f5 https://medicaldevicecourses.com/activity/p/15081/ Wed, 15 May 2019 19:02:52 -0400 The design review meetings were held with the head of the departments and each of the changes were reviewed and if anyone had any input to what else should be added or if any other changes should be made. These…   Read more»

]]> 2883f8b182dcad66f15c34ceb02c6d3f https://medicaldevicecourses.com/activity/p/15080/ Wed, 15 May 2019 19:02:51 -0400 At Prosidyan, the engineers redline the latest version of a document online using track changes. Before redlining, the engineer will create a DCO(document change order) with new revision and why changes are being made.The document record must be attached to…   Read more»

]]> c5d212007666b14948fc87ba8466918e https://medicaldevicecourses.com/activity/p/15079/ Wed, 15 May 2019 19:02:51 -0400 Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to…   Read more»

]]> c6b964e4309c56fc223da5e786e2472b https://medicaldevicecourses.com/activity/p/15014/ Wed, 15 May 2019 19:02:11 -0400 I do not agree with this statement of the book. I do not think medical device companies “lack transparency and proper clinical trials”. None of the medical devices will be in the market if they were not good. The FDA…   Read more»

]]> e5279a1668924cd1f178d824b1b53d05 https://medicaldevicecourses.com/activity/p/15010/ Wed, 15 May 2019 19:02:09 -0400 I think that all the companies should go forward with the initial planning of the the project. Once the project is proposed, there is a chance the company might getting funding. It not, it was always a good risk to…   Read more»

]]> 2b40a12134b71f5c9c40116a3328d3a6 https://medicaldevicecourses.com/activity/p/14985/ Wed, 15 May 2019 19:01:57 -0400 The past summer, I did an internship with Prosidyan. They are a medical device company which create and produce bone graft substitutes. The company’s customers were mainly doctors/surgeons at hospitals. We would send the material to the hospitals around the…   Read more»

]]> 7b9ba941d32784ca9a687bd8088f945b https://medicaldevicecourses.com/activity/p/14889/ Wed, 15 May 2019 19:01:05 -0400 The classification should not and will not change when the material is changed. Of course a PMA will be needed will filling out the paperwork but even if it is a new material, the class will not differ. This is…   Read more»

]]> b02d5c1096d7a4751b41e32c847df0bd https://medicaldevicecourses.com/activity/p/14887/ Wed, 15 May 2019 19:01:04 -0400 Project proposal should be done with extensive research of the device you are proposing along with how it will help the consumer. It should include the market gap between the competitors and how money it will bring to the company….   Read more»

]]> 8d21110666bf66c675714dacd84e713c https://medicaldevicecourses.com/activity/p/14882/ Wed, 15 May 2019 19:01:02 -0400 Regardless of the project’s type, size and scope, it is important to create a high-performance quality plan template that includes all the tasks and activities required for setting up quality targets, assuring expected performance levels, controlling changes occurring in the…   Read more»

]]> 4387075d58cc74a94564ed8438fa4a55 https://medicaldevicecourses.com/activity/p/14725/ Wed, 15 May 2019 18:59:31 -0400 I have had design control experience in the industry as well as in academics. In the industry, I have had only the chance to read through all the design controls. But when I took Dr. Simon’s class last semester, I…   Read more»

]]> 928f7522b3bdb0186b48a2956fbeb3cf https://medicaldevicecourses.com/activity/p/14718/ Wed, 15 May 2019 18:59:28 -0400 I have had a pleasure interning with two companies in the past two years. My project managers for both companies have had a management style of giving me enough freedom to finish the work they have given me in however…   Read more»

]]> caef1d6824b31e2c7dd2f8bc3f45dcaa https://medicaldevicecourses.com/activity/p/14607/ Wed, 15 May 2019 18:58:26 -0400 These skills are important because if you are not able to communicate with others, how is it possible to get work done? At a job, you need to keep everyone posted about what you are doing and if you need…   Read more»

]]> 07945f3029da18d7e7ad9aabdb5b86f3 https://medicaldevicecourses.com/activity/p/14604/ Wed, 15 May 2019 18:58:25 -0400 It’s not in the engineering world where you need to know how to convey your ideas, I believe it is something that every single person should know how to do. If you don’t know how to talk to others or…   Read more»

]]> d3c2fabd65bdaa466fb8d7bb998833d5 https://medicaldevicecourses.com/activity/p/14598/ Wed, 15 May 2019 18:58:22 -0400 I think that the big companies should keep the low priorities projects. When they do that there will be more benefits from it since all of the projects are completed no matter how small or low priority they are. The…   Read more»

]]> 5dd5d84715722adeb575654084a2be66 https://medicaldevicecourses.com/activity/p/14457/ Wed, 15 May 2019 18:57:09 -0400 I would choose matrix for a medical device company because it is flexible to pick members for the project without having to fully remove them from throt positions. The employees must report everyday to the manager and this allows for…   Read more»

]]> c02aa660331f344615285b80ef18d468 https://medicaldevicecourses.com/activity/p/14455/ Wed, 15 May 2019 18:57:07 -0400 It would be ideal to work in a team where the members are knowledgeable in their department role and I have a good relationship with. When you have this combo, it is a setup for success. When you have someone…   Read more»

]]> 9a706a5847423791d499f50d1971404e https://medicaldevicecourses.com/activity/p/14428/ Wed, 15 May 2019 18:56:52 -0400 I think I would be best suited for the middle management because I can be a manager and delegate on the project work but I will also still be responsible for some technical work to get done for the project….   Read more»

]]> b4698f625a3b120ee9df584542aed723 https://medicaldevicecourses.com/activity/p/14426/ Wed, 15 May 2019 18:56:01 -0400 For both the companies I interned at, had me sign non compete agreements. I had to agree that I would not work at a competing company for at least a year I was done interning with this company. This was…   Read more»

]]> e72684b0778d5f5f459c7ab7a68f17ef https://medicaldevicecourses.com/activity/p/14425/ Wed, 15 May 2019 18:56:00 -0400 For me personally, written agreements are better because it is set in stone and nothing can be forgotten. If a verbal agreement is made, some of the things maybe forgotten by one or all members of the agreement. Projects can…   Read more»

]]> 80915764d7890d2e13fd9d8f3e3bbaeb https://medicaldevicecourses.com/activity/p/14418/ Wed, 15 May 2019 18:55:57 -0400 The restrictions that the gifts have to be less than $100 and have to be educational is a bit restricted I believe. I agree with the fact that the gifts should be educational but putting a number on how much…   Read more»

]]> 1ac6abcb5e78eb3d00c8bee32ff13bee https://medicaldevicecourses.com/activity/p/14150/ Wed, 15 May 2019 18:52:31 -0400 Regulations are very important to any company because the products have to follow a certain standard for safety. Some people may argue that it is unfair but the FDA does a really good job to ensure the standards are followed…   Read more»

]]> 60ddee0348bb49f86d00029b8779f137 https://medicaldevicecourses.com/activity/p/14148/ Wed, 15 May 2019 18:52:30 -0400 I never had the chance to sit down in a risk management meeting but as working as quality intern, I did have a chance to read an FMEA. They are very very long and there are numerous revisions. Each new…   Read more»

]]> b22841713b5eb2c8581d722595cb6c5c https://medicaldevicecourses.com/activity/p/14145/ Wed, 15 May 2019 18:52:27 -0400 To change the way we think about risk, we must avoid making six mistakes. 1. We think we can manage risk by predicting extreme events. 2. We are convinced that studying the past will help us manage risk. 3. We…   Read more»

]]> c82cfc77ab17a375678906984d2153ca https://medicaldevicecourses.com/activity/p/13967/ Wed, 15 May 2019 17:09:58 -0400 When the design controls are not proper, it may cause the project to be set back because the product can not be cleared unless everything is correct. Design controls are in place to have the product design properly so that…   Read more»

]]> 8cbf8fff63762dcff1b7b83463456757 https://medicaldevicecourses.com/activity/p/13966/ Wed, 15 May 2019 17:09:57 -0400 Gantt charts are very important to the project because it highlights the milestones for the project. The critical path is crucial because it ensures the project is running on time and there will be no issues when moving onto the…   Read more»

]]> e8c05578d31015f410e5f4e868b238cc https://medicaldevicecourses.com/activity/p/13965/ Wed, 15 May 2019 17:09:56 -0400 Design reviews are very important in the success of the product and the company. I have had the pleasure of sitting in a design review meeting in my past internship. The project manager and the engineers involved in the project…   Read more»

]]> d91bc13eaf9ec8f0d848e08112cb76c0 https://medicaldevicecourses.com/activity/p/13929/ Wed, 15 May 2019 17:09:30 -0400 Basically what the FDA looks for when they do an audit is to ensure all the documentation is proper and all the protocols are being followed properly. The FDA will try to find anything to mark down. They are not…   Read more»

]]> 41456aa823f209d6a823848b8fdab574 https://medicaldevicecourses.com/activity/p/13854/ Wed, 15 May 2019 17:08:50 -0400 A DHF is a design history file which is a formal document that is prepared for each document. The DHF contains all the documents needs to produce the product. It contains all the design stuff along design review meetings and…   Read more»

]]> 105fd3b7b5ef4984bf2ce1fd596bad04 https://medicaldevicecourses.com/activity/p/13829/ Wed, 15 May 2019 17:08:36 -0400 Minutes for meetings are very crucial to a company because it keeps track of everything and what everyone said. We go to many meetings every week and sometime we have more than one meeting a day also. We can not…   Read more»

]]> 164966cd9afb349746fc8e3f694f3f68 https://medicaldevicecourses.com/activity/p/13769/ Wed, 15 May 2019 17:08:03 -0400 Placebo controlled trials are needed for clinical trials and they are ethical. As humans, we tend to overthink and overanalyze situations when it is not needed. Most of the placebo trials are done because we feel that medication will help…   Read more»

]]> 61be717282638c43b29983c8929a76d2 https://medicaldevicecourses.com/activity/p/13766/ Wed, 15 May 2019 17:08:01 -0400 I think I would like the role of Clinical Quality Assurance Auditor(CQA). Any clinical trial will have a lot of paperwork from the consent forms to the update of the procedure. This might be a tedious job but I believe…   Read more»

]]> 0682795c35a2fb9d828b54dab86d3db4 https://medicaldevicecourses.com/activity/p/13757/ Wed, 15 May 2019 17:07:57 -0400 I agree with the points the above students have stated. Clinical trials are done because doctors are trying to improve science and medication. There are many ways to test if a medication or a procedure will work but in certain…   Read more»

]]> 20d517d2dea090ac409439e88eb98610 https://medicaldevicecourses.com/activity/p/13605/ Wed, 15 May 2019 17:06:26 -0400 The four P’s are undoubtedly all equally important. This strategy is a business tool used by a company to produce a desired response from its target market and it consists of everything a company can do to promote demands for…   Read more»

]]> bf125d5c319e3701f18b17b475493c29 https://medicaldevicecourses.com/activity/p/13470/ Wed, 15 May 2019 17:05:09 -0400 A public company trades in the stock market publicly while the private one does not. A pro about private companies is that do not have to disclose corporate financial information while public companies have to. Because for the private companies…   Read more»

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