https://medicaldevicecourses.com/members/gsharma/activity/ Activity feed for gsharma. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 764fab58a7741b678568c9be42b524c2 https://medicaldevicecourses.com/activity/p/17233/ Wed, 15 May 2019 21:37:48 -0400 I think in a project team you need team members who can carry out the workload. The team should be comprised with individuals from different groups with knowledge of a specific subject matter or with a specific skill set who…   Read more»

]]> 17ed0da8abee9a6d06d5dbc9b0151d60 https://medicaldevicecourses.com/activity/p/17232/ Wed, 15 May 2019 21:37:48 -0400 An organization involving all structures at various levels could be very effective. A fundamentally functional organization with special project team to handle critical project. A team that may have many of the characteristics of a project team in a projectized…   Read more»

]]> 7f619860d488f148db60340fba968a74 https://medicaldevicecourses.com/activity/p/17231/ Wed, 15 May 2019 21:37:47 -0400 Matrix organizational structure would be the best case scenario for this project. Matrix organizations are a blend of functional and projectized characteristics. A matrix organization is defined as one in which there is dual or multiple managerial accountability and responsibility….   Read more»

]]> d5ca9b6a07a69fa529a881e7253fc10b https://medicaldevicecourses.com/activity/p/17156/ Wed, 15 May 2019 21:37:07 -0400 Failure Modes and Effects Analysis identifies the opportunities for failure in each step of the process. Each failure mode gets a numeric score that quantifies (a) likelihood that the failure will occur, (b) likelihood that the failure will not be…   Read more»

]]> fd36995b459f496e4ec0145f1b7d0205 https://medicaldevicecourses.com/activity/p/17155/ Wed, 15 May 2019 21:37:06 -0400 Typically Avoid, Transfer, Mitigate and Accept strategies are used from a high severity risk to low severity risk depending on the scope of the risk. Risk avoidance involves changing the project management plan to eliminate the threat entirely and may…   Read more»

]]> 636fe17df6659a0e44f5dabfb1bd1bc9 https://medicaldevicecourses.com/activity/p/17153/ Wed, 15 May 2019 21:37:05 -0400 The Risk management increases the probability and impact of positive events and decrease the probability and impact of negative events. This process of identifying the risks includes risk management planning, identification, analysis, response planning and monitoring and control on a…   Read more»

]]> a76265709c4254b0338981d859fa542a https://medicaldevicecourses.com/activity/p/17017/ Wed, 15 May 2019 21:35:56 -0400 Design Control states that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met. It sets practices and procedures to assure that the…   Read more»

]]> bb496219bbb3f6e5770f9bba094fcc17 https://medicaldevicecourses.com/activity/p/17016/ Wed, 15 May 2019 21:35:56 -0400 Design input document: The purpose is to give the reader a broad general understanding of the system or component. There may be many levels of design documents. It contains the physical and performance requirements of a device that are used…   Read more»

]]> c7557c3856e77701fbf8a09d1a77ca64 https://medicaldevicecourses.com/activity/p/17011/ Wed, 15 May 2019 21:35:54 -0400 The user needs you have defined should be the primary source for your design inputs. When a team is involved, you get everyone’s experience and opinions, which will make the effort stronger. Besides user needs and the team, there are…   Read more»

]]> 590f8d0d85daf95aabe9b52c57607704 https://medicaldevicecourses.com/activity/p/16862/ Wed, 15 May 2019 21:34:37 -0400 Clinical research are the fastest way to find effective treatments, improve standards of care, and identify methods to improve health care. Participating in clinical research is essential for the development of new medications and new treatments. Participants volunteer to gain…   Read more»

]]> 06e6f4f41fc7f8b308edddac2169c7f3 https://medicaldevicecourses.com/activity/p/16859/ Wed, 15 May 2019 21:34:36 -0400 Placebo controlled experiment is a study where controlled group is given a placebo while another group is given the drug that is being tested. This way the results can be compared with the placebo group. Placebo is meant to look…   Read more»

]]> 963948cf888d1c30d1c07b932f79094c https://medicaldevicecourses.com/activity/p/16858/ Wed, 15 May 2019 21:34:36 -0400 In a single blind experiment, the subjects don’t know if they are the experiment test group or members of the control group but the tester knows. The subjects are not told their identities in the experiment. The subject receiving the…   Read more»

]]> 1ad6d2f915a2a0b632cafa8c2b4bdbb8 https://medicaldevicecourses.com/activity/p/16753/ Wed, 15 May 2019 19:42:15 -0400 One of the most common ways to market a new product is through medical device representatives. Medical device representative helps both surgeons and patients by providing useful information and training. They help ensure that the surgeon use the device correctly,…   Read more»

]]> 05d8184de824444bbe160ad8835545ea https://medicaldevicecourses.com/activity/p/16737/ Wed, 15 May 2019 19:42:07 -0400 According to identifying and evaluating business strategies there are about 17 gran strategies that describe program of action and resource allocations. These strategies include concentration, market development, product development, innovation, horizontal integration, vertical integration, concentric diversification, Conglomerate diversification,…[Read more]

]]> 4a4a7d14a16d92319f4f478845f11d6f https://medicaldevicecourses.com/activity/p/16733/ Wed, 15 May 2019 19:42:05 -0400 The colors that a company chooses to represent their brand can affect the feelings, mood and behavior of their target consumer and influence whether or not a brand will become part of their selection set. The color branding used for…   Read more»

]]> 9a04e12108123fc14bc347c38789f6d7 https://medicaldevicecourses.com/activity/p/16667/ Wed, 15 May 2019 19:41:25 -0400 As mentioned by ih37, the biggest difference between a public company and private company is that you could buy shares of the public company and the company is required to file quarterly earnings reports with Securities and Exchange Commission. This…   Read more»

]]> d8ad04696dd560303fa11cf2017fea4c https://medicaldevicecourses.com/activity/p/16661/ Wed, 15 May 2019 19:41:22 -0400 I would consider someone for business partnership if I am able to trust them and their ability to handle the business. I will consider them if he/she shares the same professional values, ideas and goals and how they handle everyday…   Read more»

]]> bedb4f67c1f954ab16a213bd59a2e568 https://medicaldevicecourses.com/activity/p/16651/ Wed, 15 May 2019 19:41:16 -0400 I would like to be part of General Partnership Corporation where 2 or more people are involved in starting a business and contributing money, skills and labor towards the business. General partnership is the most common type of partnership. The…   Read more»

]]> aa09a8c2543ea2469c2d55f9621d64f4 https://medicaldevicecourses.com/activity/p/16512/ Wed, 15 May 2019 19:39:55 -0400 Quality Control controls the quality of the product to ensure customer requirements and needs are meet and Quality Assurance assures that quality requirements will be meet based on customers, FDA, regulations, certifiers and 3rd parties. QA and QC works together…   Read more»

]]> 595afa1124ba9eed4e199780767a6c9c https://medicaldevicecourses.com/activity/p/16509/ Wed, 15 May 2019 19:39:53 -0400 I think one of the way to have better relationship within the departments is to improve communication and ways of communication. Departments should realize that they are working for the same company towards a common goal. Department managers should know…   Read more»

]]> e6d9896429899ffcf68d3c4caf54d5dd https://medicaldevicecourses.com/activity/p/16508/ Wed, 15 May 2019 19:39:53 -0400 Document control is an important method that refines the document management system. Document control reduces documentation error and ensures that the data is searchable, information is secured and documents are consistent. Depending on the company and the industry, live documents…   Read more»

]]> 13e7e031c4bb7503e6d13fc3dc7328d2 https://medicaldevicecourses.com/activity/p/16425/ Wed, 15 May 2019 19:39:11 -0400 It is very important that the medical devices actually do what it says it will do. This is one of the requirement in the medical device amendments of 1976 that the medical device must be safe, effective and labeled properly….   Read more»

]]> 4ea59804b37c869efa74ed6679bd5dcb https://medicaldevicecourses.com/activity/p/16420/ Wed, 15 May 2019 19:39:04 -0400 There is a list of drugs on FDA website that have been recalled to protect public health from defective or potential harmful product. Some on the products included on the list are: Nasal Products, Baby oral gels, Homeopathic medicines, hydrochlorothiazide…   Read more»

]]> 44770dead1eeeafd245cf4063115e7d5 https://medicaldevicecourses.com/activity/p/16418/ Wed, 15 May 2019 19:39:03 -0400 The FDA has to be very strict to protect public health by regulations to oversee food, drugs, cosmetics and medical devices. It is true that lenient FDA regulations could increase innovation in technologies to create improved drugs and medical devices…   Read more»

]]> 33ffb25d24ed37fcb4c1b9acda6e57ee https://medicaldevicecourses.com/activity/p/16306/ Wed, 15 May 2019 19:37:57 -0400 Scientist know that there’s an ethical concern with animal testing and they have widely accepted the three Rs ethical principal for Replacement, Reduction and Refinement. Reduction: reducing the number of animals in experiment. Strategy that will result in fewer number…   Read more»

]]> 125e32eb4970690338c91cfa95d91bb6 https://medicaldevicecourses.com/activity/p/16304/ Wed, 15 May 2019 19:37:56 -0400 As mentioned before, biocompatibility testing must be performed in accordance to ISO 10993 and other FDA relevant standards. The type of testing depends on the type of device: surface, external or implant device. The biocompatibility testing will also depend on…   Read more»

]]> aa146cd9b25d273d6a50e81472d4784b https://medicaldevicecourses.com/activity/p/16302/ Wed, 15 May 2019 19:37:55 -0400 It is unethical to perform animal testing however that is the optimum way as test subject to gain knowledge about potential human treatments. Animal study and experimentation can be very useful for advancing medical science. One should learn but keep…   Read more»

]]> 89345e40e1714b63548adaaeacafd8de https://medicaldevicecourses.com/activity/p/16197/ Wed, 15 May 2019 19:18:12 -0400 I have never heard of multiple project managers for the same project. There can only be one project manager per project. There are department managers involved in multiple projects or one project manager involved in multiple projects. The way a…   Read more»

]]> 7f10837a944e0d04e3bbba13d30354aa https://medicaldevicecourses.com/activity/p/16195/ Wed, 15 May 2019 19:18:10 -0400 The work breakdown structure represents all products and project work. It shows the total work from lowest levels to the highest levels so that nothing is left out and no extra work is completed. The WBS elaborates the work required…   Read more»

]]> 4a8dcbe1e6d626a1a08ec9c75dde4f1d https://medicaldevicecourses.com/activity/p/16171/ Wed, 15 May 2019 19:17:54 -0400 Project manager faces many challenges in medical device industry compared to project manager involved in construction of a school or skyscraper. Project manager in medical device industry faces increased clinical and regulatory standards that are being FDA regulated. Project manager…   Read more»

]]> cefa7f734fb4f60c88c3a0704253d48b https://medicaldevicecourses.com/activity/p/16167/ Wed, 15 May 2019 19:17:51 -0400 I think all phases of project management are very crucial for the project. Each project has to go through all 5 phases successfully to have an ideal outcome. If I was to rate the phases based on the importance and…   Read more»

]]> 4522b25efe11320e8576ba37d6a1f3aa https://medicaldevicecourses.com/activity/p/16166/ Wed, 15 May 2019 19:17:50 -0400 I think MS would be the most optimum option for anyone’s career track. But as far as the education or the number of degrees are concerned, the more the merrier. I haven’t seen a single person with PhD who does…   Read more»

]]> 5d659043f9d58f648ea5b65c997174c2 https://medicaldevicecourses.com/activity/p/16165/ Wed, 15 May 2019 19:17:49 -0400 True, to some extent. When get out in the industry you will meet people with both experts of all trades and masters of one trade. People who are expert in their own field or people who have a lot of…   Read more»

]]> 4771464df1f46154b0ef128c55df0871 https://medicaldevicecourses.com/activity/p/16164/ Wed, 15 May 2019 19:17:49 -0400 I believe there should be 50:50 ratio of practical and academic courses throughout the degree program. You can read as much as you want about running an instrument but until you actually run it, you’re not proficient enough. You could…   Read more»

]]> ab1913424a13d65cd6d0f6cb368d3b39 https://medicaldevicecourses.com/activity/p/9056/ Wed, 21 Nov 2018 04:26:03 -0500 I think in a project team you need team members who can carry out the workload. The team should be comprised with individuals from different groups with knowledge of a specific subject matter or with a specific skill set who carry out the work of the project. Project team members should be able to: contribute to overall project objectives,…[Read more]

]]> 0 7b000d6e95ace5e4b63ae7a57f5511e1 https://medicaldevicecourses.com/activity/p/9055/ Wed, 21 Nov 2018 04:02:25 -0500 An organization involving all structures at various levels could be very effective. A fundamentally functional organization with special project team to handle critical project. A team that may have many of the characteristics of a project team in a projectized organization. The team may include full time staff from different functional…[Read more]

]]> 0 bead5e57745615d4871abe4f1df25f98 https://medicaldevicecourses.com/activity/p/9054/ Wed, 21 Nov 2018 03:40:06 -0500 Matrix organizational structure would be the best case scenario for this project. Matrix organizations are a blend of functional and projectized characteristics. A matrix organization is defined as one in which there is dual or multiple managerial accountability and responsibility. The balanced matrix organization recognizes the need for a project…[Read more]

]]> 0 c25e604197a35281271b52bbc180d365 https://medicaldevicecourses.com/activity/p/8975/ Sun, 18 Nov 2018 04:08:50 -0500 Failure Modes and Effects Analysis identifies the opportunities for failure in each step of the process. Each failure mode gets a numeric score that quantifies (a) likelihood that the failure will occur, (b) likelihood that the failure will not be detected, and (c) the amount of harm or damage the failure mode may cause to a person or to…[Read more]

]]> 0 7c0783a5198fa3e423d7d2aa5b2df62f https://medicaldevicecourses.com/activity/p/8974/ Sun, 18 Nov 2018 03:40:11 -0500 Typically Avoid, Transfer, Mitigate and Accept strategies are used from a high severity risk to low severity risk depending on the scope of the risk. Risk avoidance involves changing the project management plan to eliminate the threat entirely and may involve changing the objective that is in jeopardy. Risk transfer involves shifting some or all…[Read more]

]]> 0 729604670cac63b4bd6c35bbe89b57b0 https://medicaldevicecourses.com/activity/p/8972/ Sun, 18 Nov 2018 03:13:02 -0500 The Risk management increases the probability and impact of positive events and decrease the probability and impact of negative events. This process of identifying the risks includes risk management planning, identification, analysis, response planning and monitoring and control on a project. Once a risk is identified through the indentification…[Read more]

]]> 0 c9b1660957fd3fbf62cf8dedc69a5dea https://medicaldevicecourses.com/activity/p/8827/ Mon, 05 Nov 2018 21:42:28 -0500 Design Control states that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met. It sets practices and procedures to assure that the device meets user needs, intended uses and specific requirements. Design control…[Read more]

]]> 0 7de8bf6cdb80cefc29db056d509f8f10 https://medicaldevicecourses.com/activity/p/8826/ Mon, 05 Nov 2018 21:20:37 -0500 Design input document: The purpose is to give the reader a broad general understanding of the system or component. There may be many levels of design documents. It contains the physical and performance requirements of a device that are used as basis for device design. It appropriately addresses needs of user and patient. The purpose is to give the…[Read more]

]]> 0 3009864e340437f8ed76c7c2f1673384 https://medicaldevicecourses.com/activity/p/8821/ Mon, 05 Nov 2018 17:45:00 -0500 The user needs you have defined should be the primary source for your design inputs. When a team is involved, you get everyone’s experience and opinions, which will make the effort stronger. Besides user needs and the team, there are several more sources you should consider while defining design inputs: Industry standards, Regulations, Previous p…[Read more]

]]> 0 51d8e2c5f2f9b1cc09d24c89ad22a0ee https://medicaldevicecourses.com/activity/p/8665/ Sun, 28 Oct 2018 04:01:00 -0400 Clinical research are the fastest way to find effective treatments, improve standards of care, and identify methods to improve health care. Participating in clinical research is essential for the development of new medications and new treatments. Participants volunteer to gain access to new medicine, therapies, and/or medical devices before they…[Read more]

]]> 0 c3e1197e2b2b736b564598c116d1374f https://medicaldevicecourses.com/activity/p/8662/ Sun, 28 Oct 2018 02:32:46 -0400 Placebo controlled experiment is a study where controlled group is given a placebo while another group is given the drug that is being tested. This way the results can be compared with the placebo group. Placebo is meant to look just like a treatment or medicine, but in reality is not. It is just a look-alike treatment. All test subjects in a…[Read more]

]]> 0 c1512c71b802e4000f17f66a188067bb https://medicaldevicecourses.com/activity/p/8661/ Sun, 28 Oct 2018 01:46:33 -0400 In a single blind experiment, the subjects don’t know if they are the experiment test group or members of the control group but the tester knows. The subjects are not told their identities in the experiment. The subject receiving the medicine would not know if they were receiving the drug or the placebo. In the double blind experiment, both the…[Read more]

]]> 0 602ae8e169509759203641b6c6932743 https://medicaldevicecourses.com/activity/p/8548/ Sun, 21 Oct 2018 02:41:04 -0400 One of the most common ways to market a new product is through medical device representatives. Medical device representative helps both surgeons and patients by providing useful information and training. They help ensure that the surgeon use the device correctly, thereby improving the patents health and safety. This way the medical device…[Read more]

]]> 0 1fd460993d57d1ed4c6f94290256cea3 https://medicaldevicecourses.com/activity/p/8532/ Sat, 20 Oct 2018 22:36:33 -0400 According to identifying and evaluating business strategies there are about 17 gran strategies that describe program of action and resource allocations. These strategies include concentration, market development, product development, innovation, horizontal integration, vertical integration, concentric diversification, Conglomerate diversification,…[Read more]

]]> 0 36a359889b5737d3659669ac8436695a https://medicaldevicecourses.com/activity/p/8528/ Sat, 20 Oct 2018 19:48:07 -0400 The colors that a company chooses to represent their brand can affect the feelings, mood and behavior of their target consumer and influence whether or not a brand will become part of their selection set. The color branding used for marketing usually depends on the industry or the type of product. Different shades of green are being used to evoke…[Read more]

]]> 0 71dba02688151b1297a07a91b4f19881 https://medicaldevicecourses.com/activity/p/8453/ Sun, 14 Oct 2018 20:41:44 -0400 As mentioned by ih37, the biggest difference between a public company and private company is that you could buy shares of the public company and the company is required to file quarterly earnings reports with Securities and Exchange Commission. This gives public companies advantage to raise capital to expand the business by selling stocks and…[Read more]

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