https://medicaldevicecourses.com/members/smitshah/activity/ Activity feed for smitshah. Fri, 24 Apr 2026 21:48:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d39d4f6dff306ff0817e419f3742096b https://medicaldevicecourses.com/activity/p/15987/ Wed, 15 May 2019 19:15:55 -0400 I would agree with the stats since what matter for me the most when I work for a company is Exciting and Challenging Work Career growth and development Working with great people I dont like repetitive work every day I…   Read more»

]]> 4262d735ff6ddab2baf546e77b94ae73 https://medicaldevicecourses.com/activity/p/15864/ Wed, 15 May 2019 19:14:43 -0400 While retaining your employee is always beneficial to the company because that employee is knows companies culture knows the work structure of the company and also knows how to get work done from people within the company which is not…   Read more»

]]> 81e5b857d3bfa19233e21f6a19cf438f https://medicaldevicecourses.com/activity/p/15863/ Wed, 15 May 2019 19:14:43 -0400 Outsourcing is best option for those who lacks the expertise or who lacks resources and this is the case with smaller companies. But now a days major pharma company is also outsourcing there clinical trial to CRO’s because it’s found…   Read more»

]]> 6ed1869daea543c6c3d4c05380d6af8e https://medicaldevicecourses.com/activity/p/15749/ Wed, 15 May 2019 19:13:32 -0400 Work break down structure is basically tool used to help schedule,cost estimation and human resource management by breaking down a major work into various small work or thing that will be required to complete the bigger task. Various pitfalls seen…   Read more»

]]> ce31eeec0f1a6e08549a0a9a25695adb https://medicaldevicecourses.com/activity/p/15595/ Wed, 15 May 2019 19:08:03 -0400 Metrics give us very important details on the project. A comparison between True value and projected value gives you insight on budget spent while a comparison between Standard Variance gives you insight on where you stand in terms of timeline…   Read more»

]]> c8acf97b69cf8c8ceb67eab81d938b55 https://medicaldevicecourses.com/activity/p/15588/ Wed, 15 May 2019 19:07:58 -0400 So I was working on my Capstone project for which we received sponsorship. It was a automated muscle stimulator for atrophy patient. While working on the project we first laid down timeline and we made milestone to complete and since…   Read more»

]]> 45bcb26ed1df30dcd4ce7afbbd3c490b https://medicaldevicecourses.com/activity/p/15463/ Wed, 15 May 2019 19:06:38 -0400 according to me schedule variance can occur due multiple factor especially those factor which affect the causes your project to lack behind in terms of progress and this factors are: Poor baseline schedule (does it reflect reality?) Subcontractor/vendor cannot deliver…   Read more»

]]> 890c0cc1d6e4d7a8c29785603353ad29 https://medicaldevicecourses.com/activity/p/15401/ Wed, 15 May 2019 19:05:56 -0400 In such cases project manager can talk to the department head and ask for a other person from that department to get to Know about the project and get started in place of the person who had his issue. This…   Read more»

]]> 840bb5bdfef74340f9e4b21755199aff https://medicaldevicecourses.com/activity/p/15400/ Wed, 15 May 2019 19:05:55 -0400 Hi aashutosh it’s a good question to ask verification is something that you carry out to test weather your output meats your input requirement. Whereas your validation is where you check if your output meets user requirement. So for example…   Read more»

]]> e01d12ca6e4f85d1e5d19b28fdf79cbf https://medicaldevicecourses.com/activity/p/15351/ Wed, 15 May 2019 19:05:28 -0400 Changes can happen at any point of the project management lifecycle. The easiest way to make managing change on projects less of a headache is to know that it is going to happen and to plan for it. Having strategies…   Read more»

]]> 4735f81784342fef732dd85e04d14ceb https://medicaldevicecourses.com/activity/p/15348/ Wed, 15 May 2019 19:05:27 -0400 The project management schedule is a document that outlines what work needs to be done, the order in which it needs to be done, what resources are required, how they will be distributed, and how long different parts of the…   Read more»

]]> d1142c112b61b03112fe622517458af3 https://medicaldevicecourses.com/activity/p/15344/ Wed, 15 May 2019 19:05:25 -0400 Gantt chart is a real important tool which helps us keep a track of your project. It let us plan a project in advance and help keep in check very minute detail of the project. In particular in medical device…   Read more»

]]> f88fe65b9bdc3df0e75763f34074a40e https://medicaldevicecourses.com/activity/p/15145/ Wed, 15 May 2019 19:03:25 -0400 The Six Sigma management method philosophy focuses on better understanding of customer requirements, improving business systems throughout the organization, and enhancing the organization’s financial performance. It is used to improve the organization’s products, services and processes across various disciplines, including…   Read more»

]]> 0de88b4147baccaedcb320c646bd0e4a https://medicaldevicecourses.com/activity/p/15143/ Wed, 15 May 2019 19:03:24 -0400 Planning phase should cover as many pitfalls as possible for the project to complete but however hard you try its not possible to cover all of them since once you actually start doing the work you feel like the deadline…   Read more»

]]> e7055a5314a89c06c71185962fa7f91c https://medicaldevicecourses.com/activity/p/15100/ Wed, 15 May 2019 19:03:02 -0400 This is a very Interesting topic to Discuss on since its brings professional experience as well as new idea. As a PM i would first ask my team to study about the risk and complaints about other type of similar…   Read more»

]]> 9fe581f35ddcf343e6ddcc9b4b6dc1cb https://medicaldevicecourses.com/activity/p/15029/ Wed, 15 May 2019 19:02:25 -0400 I think Risk/Benefit ratio is something only used to decide at the beginning when the company has to decide whether or not to go ahead with the project. Whether the benefit is worth the risk or is Risk to high…   Read more»

]]> 10c3e8d74dc7d963a7fc9be1d427853c https://medicaldevicecourses.com/activity/p/14816/ Wed, 15 May 2019 19:00:21 -0400 If a company make any advertisement or any claim via any resources that company becomes liable to that claim in other words if company claims that’s there prosthetic limb can be used for extreme sports they have to do test…   Read more»

]]> 3c52359374382df80541bd30aa1b0fa2 https://medicaldevicecourses.com/activity/p/14813/ Wed, 15 May 2019 19:00:19 -0400 I would prefer to choose Matrix organization with a strong matrix i.e where project manager would have more power since that would mean once the project manager have the functional staff than staff has more responsibility towards project manager than…   Read more»

]]> fcbab3c2a310b53c70a3f7725bfb4e2a https://medicaldevicecourses.com/activity/p/14812/ Wed, 15 May 2019 19:00:19 -0400 Whenever there is a change made to an existing device first thing a company should do is check whether the change affect safety, efficacy and performance of the device. This information can be documented in a Letter to file (document…   Read more»

]]> 0ae69e38646b88244c9270a8d5663965 https://medicaldevicecourses.com/activity/p/14732/ Wed, 15 May 2019 18:59:35 -0400 Now a days many companies have been trying to release a multi purpose device with combination of drug and device. In this case products are classified according to nature of primary job it was originally made for but in cases…   Read more»

]]> 5afde9daa638f6516c26e1ef3e46a3f9 https://medicaldevicecourses.com/activity/p/14722/ Wed, 15 May 2019 18:59:30 -0400 I was also lately scrolling through the topic and first thing I found that this types of devices are not yet classified under fda but it has drafted to classify in class 1 device and is not going to lay…   Read more»

]]> 68ec050f48f5634ec674cd02d03f5ce4 https://medicaldevicecourses.com/activity/p/14652/ Wed, 15 May 2019 18:58:53 -0400 There have are many instances when the device has dual capabilities which falls in both the CDRH and CDER but first we have to determine what the primary purpose for device for example its a antibiotic releasing hip stem than…   Read more»

]]> 19c76e7614b7146fc3e7df8813a5f737 https://medicaldevicecourses.com/activity/p/14371/ Wed, 15 May 2019 18:55:32 -0400 I really agree with everyone above that Kick-back law is one of the thing to make sure patient gets the best service for which they come for and not something that is good for them just because sales rep offer…   Read more»

]]> 3b00a34d8981da71254c9aa1af276da2 https://medicaldevicecourses.com/activity/p/14370/ Wed, 15 May 2019 18:55:32 -0400 I liked this class a lot for the sole reason I got to know where to work and what things are needed to get to the position I like. The other thing that really I found useful that this course…   Read more»

]]> d0f7e7746c20674c623fbd17e092036c https://medicaldevicecourses.com/activity/p/14369/ Wed, 15 May 2019 18:55:31 -0400 I haven’t experienced it but one thing this non compete agreement mention mostly is that you have to pay certain amount of money to the company if you want to break the agreement But if you really impress the other…   Read more»

]]> 85abbd5a7be2119bbd527678a8233d1a https://medicaldevicecourses.com/activity/p/14328/ Wed, 15 May 2019 18:55:11 -0400 I think the best strategy over here would be one in which company can utilize its resources to the fullest. So i would say from company point of view Matrix organization are very effective where it can get its employee…   Read more»

]]> 6c2b6d49e9653f1ad3848571c40ec423 https://medicaldevicecourses.com/activity/p/14223/ Wed, 15 May 2019 18:53:09 -0400 I would like to work in Project based organization. Since I would like to work as a quality or regulatory department and I see in this it is better for person who want to work in department. the only disadvantage…   Read more»

]]> 77f6cfa809dae204f242d2c067645014 https://medicaldevicecourses.com/activity/p/14092/ Wed, 15 May 2019 18:51:50 -0400 Few of the mistake that company make that I came across are 1. Not considering opportunities – just threats 2. Confusing risk causes, risk events & impacts 3. Using checklists and not ‘scanning the horizon’ for other risks 4. Understating…   Read more»

]]> 173d742dfb6e540edef66158fc0f8c9d https://medicaldevicecourses.com/activity/p/14091/ Wed, 15 May 2019 18:51:49 -0400 I think that it worth buying this standards from regulatory department because if they are the one who are gonna finally approve our product for sales if the device specs are not withing the device specs as they have suggested…   Read more»

]]> 0ded4afa2b3f5de824130d7f4350ec3c https://medicaldevicecourses.com/activity/p/14090/ Wed, 15 May 2019 18:51:48 -0400 Factors to be considered for benefits vs Risk analysis by analysis. Uncertainty:is an important factor, since at any point in the total product life cycle, there is never 100% certainty regarding the safety, effectiveness, or quality of a device. However,…   Read more»

]]> 55e6755de4a2c4bd54ef43ce1393bba7 https://medicaldevicecourses.com/activity/p/14020/ Wed, 15 May 2019 17:10:29 -0400 Requirements for Design Controls 1. Design planning 2. Design input and output 3. Design verification and validation 4. Design review 5. Design changes 6. Design transfer 7. Design history file Design Control is in place so that all documents are…   Read more»

]]> ceea65303538ca871a7247ca051982ae https://medicaldevicecourses.com/activity/p/14018/ Wed, 15 May 2019 17:10:28 -0400 Most of the point are covered in the discussion above but I would like to add some more points to it. Cost And Efficiency Savings. Reduced Overhead. Operational Control. Staffing Flexibility. Continuity & Risk Management. Develop Internal Staff. Disadvantages: Possible…   Read more»

]]> dde4c36f64c058ff19507ff5a870e55b https://medicaldevicecourses.com/activity/p/13954/ Wed, 15 May 2019 17:09:50 -0400 Verification is the most important part in any project especially even in medical devices where there is interaction between devices and humans. Verification would make sure that device works in accordance with specification laid out in DSD. It all would…   Read more»

]]> 57651a896c43e132e7cef54a0f2f8714 https://medicaldevicecourses.com/activity/p/13869/ Wed, 15 May 2019 17:08:58 -0400 Design History file (DHF): Is a file that contains almost all the document from DID,DSD,DOD etc basically when you go back and look at this file you get to know all about the product development. It needs to be necessary…   Read more»

]]> e55db42d9aea7d1c6a8320e66cb8ecb1 https://medicaldevicecourses.com/activity/p/13867/ Wed, 15 May 2019 17:08:57 -0400 Your goals when defining Design Inputs include: Capturing all functional, performance, safety, and regulatory requirements. Build upon User Needs and intended use. Make sure Design Inputs are clear and objective. State Design Inputs in a way that allow you to…   Read more»

]]> 7ed204a6b98e0e911a9c841ad8e80db5 https://medicaldevicecourses.com/activity/p/13866/ Wed, 15 May 2019 17:08:56 -0400 As some of you mentioned to retro spectically find as many document as possible and move forward from them but here is something which I would suggest as a plan to go for especially for legacy products to get approval….   Read more»

]]> 28907b02594ff489688d91bed9abb3a2 https://medicaldevicecourses.com/activity/p/13707/ Wed, 15 May 2019 17:07:25 -0400 I think with every new procedure being introduce or proposed it always has its adv and disadvantage, but i think in case of medicine something which has proven itself in clinical trial show how safe the procedure is, Even in…   Read more»

]]> b3e8fb36a800d84d17cb150ddf365239 https://medicaldevicecourses.com/activity/p/13706/ Wed, 15 May 2019 17:07:25 -0400 I think placebo controlled trial are very important because this would help subject have control Vs experimental subject which would help better understand the trials which would help develop the treatment in an effective way. Because one should always have…   Read more»

]]> b19c2170b70d4515d8acf8e3dd0ff431 https://medicaldevicecourses.com/activity/p/13547/ Wed, 15 May 2019 17:05:57 -0400 Strengths Being the world’s leading online retailer, Amazon derives its strengths strategic advancement it has achieved on cost leadership, differentiation, and focus. This strategy has resulted in the company reaping the gains from this course of action and has helped…   Read more»

]]> 5cd42e5dc6279e4762a4a769cfdae3ac https://medicaldevicecourses.com/activity/p/13546/ Wed, 15 May 2019 17:05:57 -0400 Verb Surgical Vision: Translating technology and information through actions that matter. Mission: To empower surgeons with state of art robotics where everything is connected in way where everything is smarter,flexible, interoperable and portable. Verb surgical is a new company made…   Read more»

]]> ab69745296fee897731932e053765155 https://medicaldevicecourses.com/activity/p/13495/ Wed, 15 May 2019 17:05:23 -0400 Partnership is good from business point of view only when its a small scale business or when you have enough finances available in combination with your partner for your small business but when it comes to making business decision I…   Read more»

]]> 824fbbf221f20ecc56a46936383bcdd2 https://medicaldevicecourses.com/activity/p/13389/ Wed, 15 May 2019 17:04:30 -0400 Sole propretorship can not be sold or passed on under the law but the other way of doing this would be convert the sole propretorship into a llp which is allowed and get one of the son onboard and later…   Read more»

]]> e082b58b507d87eb4642987f98e43996 https://medicaldevicecourses.com/activity/p/13388/ Wed, 15 May 2019 17:04:30 -0400 I would register my company as c-type corporation because I believe that when you start your own business the most important thing is to arrange finances and I believe that C-type provides the best way to get finances and apart…   Read more»

]]> 72b87e9be0d26c796197ec3386f2e082 https://medicaldevicecourses.com/activity/p/13232/ Wed, 15 May 2019 17:03:07 -0400 Quality is an and should be considered as an integral part of the company. It doesn’t matter what is the size of the company but there should always be a set form of procedure to maintain accountability and flexibility to…   Read more»

]]> 38d5fb74b678b4d99abafa62fe4dca56 https://medicaldevicecourses.com/activity/p/13231/ Wed, 15 May 2019 17:03:06 -0400 R&D as well as quality comes with there own set of goal. Goal of R&d is to develop and innovate new or current technology in order to strength the position of company in the market. While quality has a goal…   Read more»

]]> 75b0fee21f072c0f356a48a31e66e71f https://medicaldevicecourses.com/activity/p/13183/ Wed, 15 May 2019 17:02:41 -0400 I have seen very few products that are being recalled very early. I think the products that are recalled very early shows how much company are concerned regarding the safety. One I would like to discuss is ATAR Reusable and…   Read more»

]]> 41267067a3e54fa8d59b84134654f877 https://medicaldevicecourses.com/activity/p/13180/ Wed, 15 May 2019 17:02:40 -0400 FDA need to be rigid and strict in order to make sure that good quality products are launched which in any way does not harm people on use, because they are someone who are trusted by so many people with…   Read more»

]]> 1d08ab854e0abdfc6b61121671f285fa https://medicaldevicecourses.com/activity/p/13039/ Wed, 15 May 2019 17:01:27 -0400 As far as science goes there is still no alternative to animal testing. There are animal model available and being currently developed but if you see the from bio chemical prospective which is a mystery in itself. If company develops…   Read more»

]]> 353697ee2a31a73ec4dbd4644136382b https://medicaldevicecourses.com/activity/p/12946/ Wed, 15 May 2019 17:00:38 -0400 Research in advancement and exploration of the unknowns in the wild. There is no definitive path if in the path we have a urge to know there are thing for which we can’t give any reason for something which is…   Read more»

]]> bb0614f79803138330898e26e22019a0 https://medicaldevicecourses.com/activity/p/12945/ Wed, 15 May 2019 17:00:37 -0400 I work as a researcher in academia I would definitely tell that in academia we learn more thing than in industry because its basically application of what we know but where as in academia we learn new things more frequently…   Read more»

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