https://medicaldevicecourses.com/members/hariharan-ganeshan-thevar/activity/ Activity feed for Hariharan Ganeshan Thevar. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a9cc72b3be3be141a527963ebb865106 https://medicaldevicecourses.com/activity/p/18367/ Wed, 15 May 2019 21:47:41 -0400 One of the most important phases of project management is known as design validation. The process of validation generally occurs as one step or multiple steps of the process, usually in stages and is used to determine if the project…   Read more»

]]> 4e9ffbab1a4032a3d2fca7472022c160 https://medicaldevicecourses.com/activity/p/18365/ Wed, 15 May 2019 21:47:40 -0400 The Project Execution is the performing the project scope of works and activities in accordance with the project baselines, plans and procedures with the resource, interface, change, schedule, cost, risk, quality, safety and environment management, and other contractual requirements. The…   Read more»

]]> ccf97e0b7b78575ac0e7240b3596b536 https://medicaldevicecourses.com/activity/p/18364/ Wed, 15 May 2019 21:47:40 -0400 It purely depends upon the Management department, most probably they hire a new employee. While interviewing the employee the policy of holidays or absence is being clearly mentioned to the candidate. If there’s a critical project, big companies either have…   Read more»

]]> 4db7102d5b0bfd9a8e0e36618a0270b9 https://medicaldevicecourses.com/activity/p/18362/ Wed, 15 May 2019 21:47:38 -0400 I got to learn the working process in the project. The simulations taught me alot and made me of from the vendors prespective point of view and from the customers point of view. This course is definitely going to help…   Read more»

]]> 8a52d92ceb02337ae40d5fa40babad48 https://medicaldevicecourses.com/activity/p/18347/ Wed, 15 May 2019 21:47:31 -0400 Project manager is the main pioneer of project work. Project manager leads the working process of Project. The project employees and manager work togetherto get the project done. There are many problems in the project work, one of problem the…   Read more»

]]> 2bde0129f37fde5d8b2ad5bc0dcb358f https://medicaldevicecourses.com/activity/p/18345/ Wed, 15 May 2019 21:47:30 -0400 The main important part to get the successful project is to have business sponsor. Without the sponsorships, it can be get difficult or else they project group people have to pay by them own. So it’s becomes important to have…   Read more»

]]> 04a6badf863ddc27632847e4316780cd https://medicaldevicecourses.com/activity/p/18283/ Wed, 15 May 2019 21:46:57 -0400 The main difference between the Engineer and the manager. The Engineer makes the stuff and the manager examines and the manager manage the employees. The relationship between the manager and employees should be good even though it goes bad, it…   Read more»

]]> c68ff490fa60fd4fd42c81e6dda6da4c https://medicaldevicecourses.com/activity/p/18282/ Wed, 15 May 2019 21:46:56 -0400 The most difficult part is to get a good vendor and to maintain a good relationship with them. First maintaining a good relationship with vendor:- 1) The one should atleast should make 5-6 orders. 2) should pay bill on time….   Read more»

]]> 4e6fcb919d7f509f78e2c895a89b8f0b https://medicaldevicecourses.com/activity/p/18281/ Wed, 15 May 2019 21:46:56 -0400 I would like to choose the investigator because it examines the medical devices before in the market to make sure that the patient is safe. The clinical investigator should also meet with the requirements set by the FDA. Primary role…   Read more»

]]> 8e7eeed9fa24c41731c13dc8e612a047 https://medicaldevicecourses.com/activity/p/18221/ Wed, 15 May 2019 21:46:24 -0400 A Gantt chart, commonly used in project management, is one of the most popular and useful ways of showing activities (tasks or events) displayed against time. On the left of the chart is a list of the activities and along…   Read more»

]]> 051b9e203f689a4127bec6dbb0abfc73 https://medicaldevicecourses.com/activity/p/18220/ Wed, 15 May 2019 21:46:23 -0400 Procurement management is the process of ensure that everything required from outside the organization is in place when it is needed so the project can proceed successfully. Failing to plan the procurement schedule or process is one of the most-costly…   Read more»

]]> e7a740bd30f669647905a9733f296360 https://medicaldevicecourses.com/activity/p/18219/ Wed, 15 May 2019 21:46:23 -0400 A communication management plan documents how the project manager manages and controls communication. All stakeholder needs must be addressed. Communication management plan becomes a part of the project management plan. Planning communications involve determining how to communicate each item. Communication…   Read more»

]]> 1d3ccb29d525059cd8426548c0656a73 https://medicaldevicecourses.com/activity/p/18211/ Wed, 15 May 2019 21:46:19 -0400 The project eventually if gets into upgradation, new skills will be needed so for that new employees plays a major role because they already have learnt those skills in the university.

]]> 362efdf5c7928a86518f36529b60a1cb https://medicaldevicecourses.com/activity/p/18074/ Wed, 15 May 2019 21:45:11 -0400 The purpose of the executing process group is to complete the work defined in project management plan and to meet project obejctives. What to do, when the order of activities, tools, materials and equipment that will be procured, the budget…   Read more»

]]> 1d782bcac96d6a2ee2bf67899f8e1573 https://medicaldevicecourses.com/activity/p/18070/ Wed, 15 May 2019 21:45:09 -0400 Work log itself defines that to maintain a proper record for the product that has been researched, manufactured and various steps involve in the process. In FDA regulations, the department examines each every record maintained and finds out the error…   Read more»

]]> 47d1b02f61a3bfdd64dd1130d70504e6 https://medicaldevicecourses.com/activity/p/18066/ Wed, 15 May 2019 21:45:07 -0400 Schedule variance helps to determine if you are behind or ahead of schedule, and cost variance helps to determine if you are under budget or over budget.
These variance give you essential about the project’s progress.

]]> ff34ee1f068a2c90cd78647dcd44126b https://medicaldevicecourses.com/activity/p/18000/ Wed, 15 May 2019 21:44:31 -0400 Risk management team itself define whether the project is in a critical stage or else problem occurred in the project sloved by risk management team. They deals with executive leadership,suppliers, team , customer and mainly project manager in order to…   Read more»

]]> 674e6ae63f5ae4d6699126c61b3ffbbd https://medicaldevicecourses.com/activity/p/17997/ Wed, 15 May 2019 21:44:29 -0400 Previously, my work experience on servicing of medical machines.In that job, I just got an overview study of the machines. But for now , I am looking jobs in R&D department. So that I can make my own design of…   Read more»

]]> f6a3b0a376da703f9ef8ea8e45904fa4 https://medicaldevicecourses.com/activity/p/17989/ Wed, 15 May 2019 21:44:26 -0400 In case of vendors, the project manager should have multiple options for vendor and should select the best. In this case, if a vendor provides a defective material, before delivery, the project manager should check the sample of the material.

]]> 2754565f0a9ce8ce25bdd846bb61bd9a https://medicaldevicecourses.com/activity/p/17929/ Wed, 15 May 2019 21:43:56 -0400 In this scenario, Project should be well planned. If the crucial employee is not available, the back up employees should have been appointed. But in most of the cases, project manager relies on the employee, forget about such situations. In…   Read more»

]]> 4e7f7ab3a688c10f6bd4dfcc33696f65 https://medicaldevicecourses.com/activity/p/17928/ Wed, 15 May 2019 21:43:55 -0400 Logging work is the most important phase in the project or either in work place. Back when I used to work with Medtronic, Employees were made to make the service and maintenance report for the breakdown calls of the machine….   Read more»

]]> ef3d0dc905787477520753cba8a4a888 https://medicaldevicecourses.com/activity/p/17882/ Wed, 15 May 2019 21:43:32 -0400 There are many types of ISO. I’ll focus on ISO:13845 which is desgined to be used by the organization involved in the design, production, installation and servicing in the medical devices and has been revised every 5 years for the…   Read more»

]]> 32608743fa10e1dd63fc01a944321b5c https://medicaldevicecourses.com/activity/p/17872/ Wed, 15 May 2019 21:43:27 -0400 Design validation is first stage for the device development and it’s most important stage. As the design of the device is made, the main job was to validate or else to check whether the design is proper or not. So…   Read more»

]]> 70d1a892e57ddccae6ae3b322515b638 https://medicaldevicecourses.com/activity/p/17852/ Wed, 15 May 2019 21:43:15 -0400 Risk/Benefit ratio sometimes leads to gain more profit and sometimes may leads to loss for the medical device. Most of the companies in other sector takes risk in order to upgrade product, While in the medical field I have noticed…   Read more»

]]> 6bd631efa5df2830df3f66d5ffaea786 https://medicaldevicecourses.com/activity/p/17801/ Wed, 15 May 2019 21:42:45 -0400 Change in the project can give benefits or else may give major risk in the project. If the project is completed and in the last stage certain changes is made, firstly the due date of the project will gets affected…   Read more»

]]> 3440812923c03c8a467f7f429ee74178 https://medicaldevicecourses.com/activity/p/17797/ Wed, 15 May 2019 21:42:43 -0400 I was service engineer in Medtronic. I used to deal with Ventriculoperitoneal Shunt, Lumboperitoneal shunt, Neuro Drills. Neuro Drills used to make burr hole in the skull, so that Minimal Invasive Surgery can be performed. I used to go for…   Read more»

]]> 0fc74f3202eb54885a4ead3ef2ff5a9d https://medicaldevicecourses.com/activity/p/17796/ Wed, 15 May 2019 21:42:42 -0400 Clinical project managers are responsible for organizing, communicating and evaluating team objectives for clinical studies. Their team might include clinical research associates and clinical specialists. Clinical project managers essentially plan and manage clinical trials in order to achieve quality results….   Read more»

]]> 3780df46d6bdcb31090da1fdd831b398 https://medicaldevicecourses.com/activity/p/17717/ Wed, 15 May 2019 21:42:03 -0400 Project integration management is a way of making various processes work together. Meaning, it takes the numerous processes that are being used in a project and makes sure that they’re coordinated. Project integration management accomplishes this by making trade-offs. That…   Read more»

]]> 3a52c42cb6ec7c177960fef2655c7fb6 https://medicaldevicecourses.com/activity/p/17714/ Wed, 15 May 2019 21:42:02 -0400 This are some steps that project manager can handle budgets:- Produce an estimate. Compile a realistic estimate with your team. Make sure it covers all the project’s phases and activities and that it contains sufficient contingency. Account for all people…   Read more»

]]> ec33c4a4164507e6b7fa1a05d829adde https://medicaldevicecourses.com/activity/p/17713/ Wed, 15 May 2019 21:42:01 -0400 Change control is a systematic approach to managing all changes made to a product or system. The purpose is to ensure that no unnecessary changes are made, that all changes are documented, that services are not unnecessarily disrupted and that…   Read more»

]]> b3974f501d7be9e82810e92f6f52c3e0 https://medicaldevicecourses.com/activity/p/17621/ Wed, 15 May 2019 21:41:08 -0400 Validation and verification should take place from the early to the final stages of our product lifecycle and even after the release of the final solution. The most commonly used methods are surveys/questionnaires, usability tests, card sorting, eye-tracking and a…   Read more»

]]> 92212ab271c7a8002a5cf2dc9924bb3a https://medicaldevicecourses.com/activity/p/17620/ Wed, 15 May 2019 21:41:08 -0400 Specs is determined during the test of the product accordingly to that the specs is also upgraded. As the product is fabricated there will be chances of some specs getting destroy in the manufacturing site. So that the reason product…   Read more»

]]> 37baf9f7ef6fee3d871db871150ff6ff https://medicaldevicecourses.com/activity/p/17619/ Wed, 15 May 2019 21:41:07 -0400 Quality plan itself defines the quality of the product, which includes certain policies, documentation, procedures and tests for the medical devices. As the medical devices already overcomes with many researches and many test on animals as well as in humans….   Read more»

]]> 49b3fbcade155a188116931881bfa44c https://medicaldevicecourses.com/activity/p/17533/ Wed, 15 May 2019 21:40:20 -0400 The medical device is generally categorized in three class:- class 1( Low moderate risk medical devices), class 2(low to moderate risk medical devices), class 3(moderate to high risk device). The categorization is been made by FDA. Every Single medical device…   Read more»

]]> 886e27c6562f0a07bf773bd6b4d5402e https://medicaldevicecourses.com/activity/p/17530/ Wed, 15 May 2019 21:40:18 -0400 Huge investment needed in medical device. Some of the small companies collaborate with each other for making a medical device. For instance, Medtronic are taking small companies like covidien just make profit and make a better product.The main reason for…   Read more»

]]> 81dd340f3de9c009931ea6add7c3b777 https://medicaldevicecourses.com/activity/p/17529/ Wed, 15 May 2019 21:40:18 -0400 There are certain protocols given by FDA, Every manufactures should go through the protocols. The main purpose of the FDA is for safety measures. Even though, there is a flaw in the design of the product cause huge problems for…   Read more»

]]> d19f470ef3f14c534e1fbaa998b7f7d3 https://medicaldevicecourses.com/activity/p/17467/ Wed, 15 May 2019 21:39:46 -0400 From my experience in Medtronic, My job was totally functional based system. I was a biomedical service engineer. I had to do certain tasks in a particular day. If there’s a emergency case in the hospital, I had to rush…   Read more»

]]> 8f8829e61841f642f707d7b92a18b5de https://medicaldevicecourses.com/activity/p/17466/ Wed, 15 May 2019 21:39:46 -0400 In order to initiate a big project, starting base level of that project should be a perfect team which plays a crucial role. For a perfect team, needs a perfect manager (leader). Team is like pyramid of project. If the…   Read more»

]]> d2a8510bd68bf6a4468ac22f3bec5866 https://medicaldevicecourses.com/activity/p/17465/ Wed, 15 May 2019 21:39:45 -0400 I think both interpersonal skills and technical skills are important in the biomedical field. For instance, If a engineer makes a medical device gradually he would be having more technical knowledge of that medical device. Now that engineer is planing…   Read more»

]]> 47403077f7ed7bb724a9d55b0914ce69 https://medicaldevicecourses.com/activity/p/10282/ Mon, 06 May 2019 03:51:31 -0400 One of the most important phases of project management is known as design validation. The process of validation generally occurs as one step or multiple steps of the process, usually in stages and is used to determine if the project is meeting specifications. The specifications of the project are highly detailed, and it is up to the project manger…[Read more]

]]> 0 0bcaebdc87751518e84e4d3a592ee12a https://medicaldevicecourses.com/activity/p/10280/ Mon, 06 May 2019 03:46:34 -0400 The Project Execution is the performing the project scope of works and activities in accordance with the project baselines, plans and procedures with the resource, interface, change, schedule, cost, risk, quality, safety and environment management, and other contractual requirements. The key success factors for the project execution is well…[Read more]

]]> 0 c3c225750150774f3a570794ef3c9b5c https://medicaldevicecourses.com/activity/p/10279/ Mon, 06 May 2019 03:40:30 -0400 It purely depends upon the Management department, most probably they hire a new employee. While interviewing the employee the policy of holidays or absence is being clearly mentioned to the candidate. If there’s a critical project, big companies either have a back up team or else they appoint a experienced candidate for emergency case.

]]> 0 f12bdb804f5cb9a312d1eb3262d68ac6 https://medicaldevicecourses.com/activity/p/10277/ Mon, 06 May 2019 03:36:15 -0400 I got to learn the working process in the project. The simulations taught me alot and made me of from the vendors prespective point of view and from the customers point of view. This course is definitely going to help me in the future as well.

]]> 0 115de4aa4d8bd1f7039aa2e313895b5c https://medicaldevicecourses.com/activity/p/10262/ Mon, 06 May 2019 01:24:12 -0400 Project manager is the main pioneer of project work. Project manager leads the working process of Project. The project employees and manager work togetherto get the project done. There are many problems in the project work, one of problem the manager is not agreeing with the employees a big debate goes on due which the project gets delay. In order…[Read more]

]]> 0 dfb5bc493619b2424adb9eeed1183dbe https://medicaldevicecourses.com/activity/p/10260/ Sun, 05 May 2019 23:32:39 -0400 The main important part to get the successful project is to have business sponsor. Without the sponsorships, it can be get difficult or else they project group people have to pay by them own. So it’s becomes important to have a strong relationship with the business sponsors. In return the business sponsors are expecting the profit from the…[Read more]

]]> 0 713314c9822497a1bb582cba299d196c https://medicaldevicecourses.com/activity/p/10195/ Mon, 29 Apr 2019 01:01:58 -0400 The main difference between the Engineer and the manager. The Engineer makes the stuff and the manager examines and the manager manage the employees. The relationship between the manager and employees should be good even though it goes bad, it affects the selling of the product and losing of customers.
The manager has the much more and authority…[Read more]

]]> 0 4c320452e31f34898251fc4d3b6e0147 https://medicaldevicecourses.com/activity/p/10194/ Mon, 29 Apr 2019 00:31:58 -0400 The most difficult part is to get a good vendor and to maintain a good relationship with them.
First maintaining a good relationship with vendor:-
1) The one should atleast should make 5-6 orders.
2) should pay bill on time.
3) if other vendors gives the discount on the product the business man can buy the product but at the same they should order…[Read more]

]]> 0 959345b4ecc41b11efc14c8f4e460569 https://medicaldevicecourses.com/activity/p/10193/ Sun, 28 Apr 2019 23:33:09 -0400 I would like to choose the investigator because it examines the medical devices before in the market to make sure that the patient is safe. The clinical investigator should also meet with the requirements set by the FDA. Primary role of investigator is to conduct research that contributes to generalize the knowledge of human rights.

]]> 0 212e2762d68166434b8c045db2e44856 https://medicaldevicecourses.com/activity/p/10132/ Mon, 22 Apr 2019 03:20:39 -0400 A Gantt chart, commonly used in project management, is one of the most popular and useful ways of showing activities (tasks or events) displayed against time. On the left of the chart is a list of the activities and along the top is a suitable time scale. Each activity is represented by a bar; the position and length of the bar reflects the start…[Read more]

]]> 0 12a24ac3d12dfc38d5d6b28024ac6220 https://medicaldevicecourses.com/activity/p/10131/ Mon, 22 Apr 2019 03:10:38 -0400 Procurement management is the process of ensure that everything required from outside the organization is in place when it is needed so the project can proceed successfully. Failing to plan the procurement schedule or process is one of the most-costly mistakes that can be made because the entire project can be brought to a halt if products or…[Read more]

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