https://medicaldevicecourses.com/members/su65/activity/ Activity feed for su65. Sat, 25 Apr 2026 04:09:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b520c17c9be0ac432d0a057a990bf236 https://medicaldevicecourses.com/activity/p/14474/ Wed, 15 May 2019 18:57:16 -0400 I think the rules set are good. Because, physician can attend business meeting but I dont think wife has anythig to do with that business meeting. We should not let money take over and hence it is good that these…   Read more»

]]> fa983374d985b524782f5a04ea1db020 https://medicaldevicecourses.com/activity/p/14473/ Wed, 15 May 2019 18:57:16 -0400 NDA is a contract between two people who agree not to disclose anything related to product and sign. A patent is a document which shows/proves the ownership of the idea. That is the idea is patented by its owner so…   Read more»

]]> e8609805f20da6f028ea60dc083eba5c https://medicaldevicecourses.com/activity/p/14468/ Wed, 15 May 2019 18:57:14 -0400 Oral agreement is limited to words spoken by people. There is no evidence unlike in written agreement. Oral agreements are difficult to defend in court unless there is a proper evidence. Written agreement is always better since there is proof/evidence…   Read more»

]]> 69a567d79e7336556829bb95da7eca66 https://medicaldevicecourses.com/activity/p/14330/ Wed, 15 May 2019 18:55:12 -0400 I would consider choosing matrix organization for my company. Matrix organization has given successful results in managing the project. It gives better allotment of resources. There will be knowledge transfer between the departments. Matrix organization helps in a more effective…   Read more»

]]> 352302e9848b6cae7347b0f12a72f743 https://medicaldevicecourses.com/activity/p/14324/ Wed, 15 May 2019 18:55:09 -0400 I think I have the technical expertise to run a project as a middle-level project manager. Also, I agree with other that, to negotiate with clients and plan/developing Strategies, one must gain enough experience to understand the company’s vision and…   Read more»

]]> a1a429de00f3703057410911e04aa2a2 https://medicaldevicecourses.com/activity/p/14323/ Wed, 15 May 2019 18:55:08 -0400 I agree with akshayakirithy and srg36. Making departments understand and work together, it is very important to bridge the gap or clear the differences between them. interdepartmental team building events can really have productive results in connecting others. Also, to…   Read more»

]]> ff4fdf123ebe5584baf17bbc67ac0d4b https://medicaldevicecourses.com/activity/p/14203/ Wed, 15 May 2019 18:53:00 -0400 It is always good to have wide variety of inputs from people at all steps of product process to analyse and identify risks because its difficult to know when and how a risk can occur. Even after the product is…   Read more»

]]> f999837f5600cae79d602723b7fa99a1 https://medicaldevicecourses.com/activity/p/14201/ Wed, 15 May 2019 18:52:59 -0400 Labelling and istructions are very important for a medical device. Its the way to tell users to how to use device. Companies while advertising the product can actually show how to use the product and also along with that its…   Read more»

]]> d6cf0dbd3c4a43f3fe0805603d303de6 https://medicaldevicecourses.com/activity/p/14196/ Wed, 15 May 2019 18:52:57 -0400 High severity risks are unacceptable because they can cause severe harm to patients. Avoidance or mitigation would be good for high severity risks. Considering risks are high, To avoid them or to eliminate them is a good option rather than…   Read more»

]]> 0045bdeadc0ae2610729d6bb192e6a1e https://medicaldevicecourses.com/activity/p/14050/ Wed, 15 May 2019 18:51:26 -0400 Devices which are used outside the body and which does not need clinical/ preclinical trials does not possess severe risks to patient. Few examples include sthethoscope, surgical tape, colostomy bags etc. These devices does not pose risks to patients and…   Read more»

]]> a558245ebae464d316e2d93101476e76 https://medicaldevicecourses.com/activity/p/14047/ Wed, 15 May 2019 18:51:25 -0400 Devices which are used outside the body and which does not need clinical/ preclinical trials does not possess severe risks to patient. Few examples include sthethoscope, surgical tape, colostomy bags etc. These devices does not pose risks to patients and…   Read more»

]]> bab7dca387638b77d2908ffe8ba406b0 https://medicaldevicecourses.com/activity/p/14044/ Wed, 15 May 2019 18:51:22 -0400 Gantt chart should have all the outline which tells the project start date, end date, each project steps like planning, designing, developing, quality, manufacturing, testing and marketing. It also includes budget planning and resource planning. The dates should be flexible…   Read more»

]]> 2e03bd7af9519d1554886b6d24ff98e1 https://medicaldevicecourses.com/activity/p/14039/ Wed, 15 May 2019 18:51:19 -0400 DDP written by project manager is important which outlines all the developments of the project. Hence it is difficult to say one part is important in DDP. I feel all the steps involved in DDP are equally important. Communication management…   Read more»

]]> 263694a29d8cb8d32f8c968207dea1bb https://medicaldevicecourses.com/activity/p/13925/ Wed, 15 May 2019 17:09:28 -0400 I feel that communication management plan is the most important because only if the people are discussing properly then they can find the flaws of a project and can be rectified in a constructive way. If there is not proper…   Read more»

]]> 8b7ce28a6d3180d22e21b222ed84b5b8 https://medicaldevicecourses.com/activity/p/13924/ Wed, 15 May 2019 17:09:27 -0400 Design controls always important for each class of medical device. For instance lets take pacemakers. If the design of pacemaker is not properly validated then the failure of pace maker would lead to the death of a human. In a…   Read more»

]]> 23d32e06505c59aaddefdacaf828229d https://medicaldevicecourses.com/activity/p/13923/ Wed, 15 May 2019 17:09:27 -0400 Despite its small geographic size, Singapore has one of the largest and most advanced healthcare systems in the world. Singapore has robust healthcare infrastructure, so there is consistent demand for state-of-the-art medical technologies. Medical devices in Singapore are regulated by…   Read more»

]]> 2a7e65a73d0acef6cefa4d93d545ac34 https://medicaldevicecourses.com/activity/p/13723/ Wed, 15 May 2019 17:07:33 -0400 Advantages and disadvantages are associated with clinical trials. Performing a clinical study is important for the drug/ device to be tested for its effectiveness, safety and risks and to come into market. If a drug or device can save thousands…   Read more»

]]> 20e832867063bc3aacac45d2022e937d https://medicaldevicecourses.com/activity/p/13721/ Wed, 15 May 2019 17:07:32 -0400 I would like to become a Clinical Research Associate if i would take part in a clinical research. It directly involves in carrying out clinical trials to test the effectiveness, safety, benefits and risk associated with the drug/ device so…   Read more»

]]> 12e768446f8c2ca9d16008732bfde98c https://medicaldevicecourses.com/activity/p/13719/ Wed, 15 May 2019 17:07:31 -0400 Clinical experience is not needed for all the roles. Roles which does not involve any interaction with patients, communication with patients like statistician etc does not need any clinical experience. But for roles which is directly involved with patient interactions…   Read more»

]]> c50efa1b7191f17b0418ee130fa265ce https://medicaldevicecourses.com/activity/p/13601/ Wed, 15 May 2019 17:06:24 -0400 Emotional Intelligence helps companies to understand the customers emotions, mood, behaviour and to control them. It helps companies connect with the customers, have good communication to know the current needs of the customers and also to get feedback. EI is…   Read more»

]]> 59ee7d33fc96340594ff3c887ed13a68 https://medicaldevicecourses.com/activity/p/13598/ Wed, 15 May 2019 17:06:23 -0400 One of the product that is doing good without the Telisvision or other form of advertisements is Zara. It is one of the worlds largest retailers and does not have any budget for advertising. Instead of that the company uses…   Read more»

]]> 963ea9fc6821dc99a6fd7ed499a6cb89 https://medicaldevicecourses.com/activity/p/13596/ Wed, 15 May 2019 17:06:22 -0400 Social medias have become popular advertising sites too. The fifth p, participation, is easily now a days being used in social medias like facebook, twitter, instagram, linkedin etc.Companies adverstise their product by making a short videos which can attract and…   Read more»

]]> 65b9bd5520123617514d07c5db17c5c2 https://medicaldevicecourses.com/activity/p/13497/ Wed, 15 May 2019 17:05:24 -0400 Sole proprietorship cannot be passed on or transferred from dad to his sons. Unfortunately if dad dies, then the assests/company cannot be taken by his childern. His sons has no rights on the company their dad created. So in case…   Read more»

]]> d338fa553547faca31725448484e2e0f https://medicaldevicecourses.com/activity/p/13492/ Wed, 15 May 2019 17:05:22 -0400 I would prefer considering Partnership in future. Partner should share a common goal and should agree the hoped-for outcomes, impacts and business for their partnership as a whole. Partners should recognise and accept that each partner organization has the right…   Read more»

]]> e7d7be5aed507f96974ce41b4e923831 https://medicaldevicecourses.com/activity/p/13489/ Wed, 15 May 2019 17:05:20 -0400 Public companies has shares which can be traded publicly on a stock market. Private company becomes a public company when it offers the shares of the company to public. Public companies are run by a board of directors. This is…   Read more»

]]> ed8c8910968feec2bba937690af40206 https://medicaldevicecourses.com/activity/p/13291/ Wed, 15 May 2019 17:03:39 -0400 The cost of the quality is very much important for a company. Quality department ensures that the product is safe before marketing. Product is tested for its safety and standard regulations set up are followed. This sets up the confidence…   Read more»

]]> 03bd241691e2f48d5b0719a9e78364d9 https://medicaldevicecourses.com/activity/p/13288/ Wed, 15 May 2019 17:03:37 -0400 R&D department works on advancement of technolgy to give a product which would help people. Quality department monitors the safety of the product before reaching the people. Quality department sees all the department as to whether the quality requirements and…   Read more»

]]> c809be7d6879eb541b6501e731565b0e https://medicaldevicecourses.com/activity/p/13287/ Wed, 15 May 2019 17:03:37 -0400 The bad relationship or conflicts between R&D department and quality department can be tried to sorted by involving the quality department into other teams, meetings and discussions from the beginning of the project. Team representatives from quality department should be…   Read more»

]]> 297104ed1b345723a29613a5c080ee55 https://medicaldevicecourses.com/activity/p/13110/ Wed, 15 May 2019 17:02:02 -0400 Recently, Bella Pharma voluntarily recalled its unexpired sterile drug products like B-complex, Methylcobalamin, Mannitol etc. The lots from April to August 2017 wree recalled. This happened due to lack of sterility assurance. The sterile drug component which had to be…   Read more»

]]> e2d710493c1d9330ed96aaa072ea22c6 https://medicaldevicecourses.com/activity/p/13104/ Wed, 15 May 2019 17:01:59 -0400 Transdermal patch is a combination product which is used to deliver drugs through skin. Currently around 17 drug molecules are approved by FDA for transdermal delivery. The patch has micro needles which will deliver the drug through the skin. The…   Read more»

]]> 7df677db04aee90b58de865ab5aec027 https://medicaldevicecourses.com/activity/p/13102/ Wed, 15 May 2019 17:01:58 -0400 The de Novo 510K process is classification procedure to classify the new medical devices which are not previously classified. The new rule has made the process easy by getting approval without the submission of 510K approval. An application is sent…   Read more»

]]> b80856383463a64f8e0a7c3162ee2b28 https://medicaldevicecourses.com/activity/p/12979/ Wed, 15 May 2019 17:00:57 -0400 Research in academia is mostly ones passion to denote their time in innovations and research for the unknown outcome. It might also be personal in addressing a problem to find a solution. Research in academia is not money oriented and…   Read more»

]]> 4fa2b012f649c0bbab8a463727408af6 https://medicaldevicecourses.com/activity/p/12977/ Wed, 15 May 2019 17:00:57 -0400 Depending on the usage/category of Biomaterials, like surface biomaterials, implants, they must undergo different types of testing which are set by ISO 10993 standards like cytotoxicity, genotoxicity, sensitization, chronic toxicity, carcinogenecity. For example, a surface biomaterial should be tested for…   Read more»

]]> b3ff1340835f175157cbc7748d797614 https://medicaldevicecourses.com/activity/p/12964/ Wed, 15 May 2019 17:00:47 -0400 I was very much interested in doing research in academia which would benefit people after a long time. But after working in academia research and seeing people getting benefited right away from industrial research, my passion started drifting towards industrial…   Read more»

]]> bc1af32dbd0c551ee3d1b1e2a929c82d https://medicaldevicecourses.com/activity/p/12881/ Wed, 15 May 2019 16:59:56 -0400 Planning and execution phase remains the most important phases. This is because in planning phase all the proper steps which are to be performed are laid out properly and in an orderly manner like allocating resources, setting deadlines, budget and…   Read more»

]]> 0b3ac687cdf977e24edc901a3bc7f3b2 https://medicaldevicecourses.com/activity/p/12874/ Wed, 15 May 2019 16:59:53 -0400 Missing a milestone in the path of the project is considerd as a failure. However, that is not the end of the project or that doesnt mean that there is any compromise in the project in regard with its quality/reliability/safety/durability….   Read more»

]]> 7ecc42be857b6072ed3dbd8f6badf23e https://medicaldevicecourses.com/activity/p/12869/ Wed, 15 May 2019 16:59:50 -0400 Being a project manager for a medical device company is more challenging than a project manager for skyscraper building company. Medical devices should pass the FDA regulations which is more complicated than the regulations followed by a skyscraper building company….   Read more»

]]> 99781d14d783a7bc58516f7e006e0a10 https://medicaldevicecourses.com/activity/p/12808/ Wed, 15 May 2019 16:59:19 -0400 Academia and Industry have their own advantages and disadvantages. I have been working in academia (research at NJIT) from 6 months and also have previous industry experience for an year. In research field, to put our ideas, create and/or invent…   Read more»

]]> 9d682f721ffac14f5759d42eb79292dd https://medicaldevicecourses.com/activity/p/12804/ Wed, 15 May 2019 16:59:17 -0400 I believe academic and practical classes ratio should be 50:50. Knowing the basic required knowledge on a subject is as important as knowing where and how it is applied. Industry demands more practical knowledge than theoretical knowledge. But the base…   Read more»

]]> 24a038d66967f44f85db61a74a56dcc5 https://medicaldevicecourses.com/activity/p/12803/ Wed, 15 May 2019 16:59:17 -0400 In academia, you can do the project having flexibility in the timing. Sometimes i used to go to lab at nights and finish my work. You can extend the deadlines depending on the time taken by the work to complete….   Read more»

]]> 0a23154df97d08b878620f4be9f0db56 https://medicaldevicecourses.com/activity/p/5527/ Mon, 04 Dec 2017 02:44:51 -0500 I think the rules set are good. Because, physician can attend business meeting but I dont think wife has anythig to do with that business meeting. We should not let money take over and hence it is good that these rules are set. This will not give chance for bribery.

]]> 0 ef0b54fb6f487fe080bf1ac8b34d069f https://medicaldevicecourses.com/activity/p/5526/ Mon, 04 Dec 2017 02:39:20 -0500 NDA is a contract between two people who agree not to disclose anything related to product and sign. A patent is a document which shows/proves the ownership of the idea. That is the idea is patented by its owner so as to protect his/her idea. NDA is signed prior to the patent process.

]]> 0 005966271ca2d7442ac69ffcb15a125d https://medicaldevicecourses.com/activity/p/5521/ Mon, 04 Dec 2017 02:27:55 -0500 Oral agreement is limited to words spoken by people. There is no evidence unlike in written agreement. Oral agreements are difficult to defend in court unless there is a proper evidence. Written agreement is always better since there is proof/evidence that can be shown in court in case of any legal disputes.

]]> 0 97e08b3309f9469f7fd9709c782e3b59 https://medicaldevicecourses.com/activity/p/5372/ Mon, 27 Nov 2017 04:30:14 -0500 I would consider choosing matrix organization for my company. Matrix organization has given successful results in managing the project. It gives better allotment of resources. There will be knowledge transfer between the departments. Matrix organization helps in a more effective way of running a project.

]]> 0 2538a4c0d4a285439025dbf5be069873 https://medicaldevicecourses.com/activity/p/5366/ Mon, 27 Nov 2017 04:10:11 -0500 I think I have the technical expertise to run a project as a middle-level project manager. Also, I agree with other that, to negotiate with clients and plan/developing Strategies, one must gain enough experience to understand the company’s vision and goals. Hence, climbing the ladder from bottom to top along with experience is my way of growing.

]]> 0 d260880d66b95b890e4b1aad3db6b262 https://medicaldevicecourses.com/activity/p/5365/ Mon, 27 Nov 2017 04:09:25 -0500 I agree with akshayakirithy and srg36. Making departments understand and work together, it is very important to bridge the gap or clear the differences between them. interdepartmental team building events can really have productive results in connecting others. Also, to have a strong and motivating project manager generally solves all of these problems.

]]> 0 2a808310640c0b594c5f575dface161d https://medicaldevicecourses.com/activity/p/5237/ Mon, 20 Nov 2017 04:47:43 -0500 It is always good to have wide variety of inputs from people at all steps of product process to analyse and identify risks because its difficult to know when and how a risk can occur. Even after the product is in the market, a company should keep a track of how the product is functioning, are there any risks which have occured etc. From these data…[Read more]

]]> 0 6fc2018edecea0a762b650c290a6227c https://medicaldevicecourses.com/activity/p/5235/ Mon, 20 Nov 2017 04:33:11 -0500 Labelling and istructions are very important for a medical device. Its the way to tell users to how to use device. Companies while advertising the product can actually show how to use the product and also along with that its good to tell the associated risks if not used in the way it should be used. Like this it can create little awareness in the…[Read more]

]]> 0 7e5571b705afd2945e289ccf47267701 https://medicaldevicecourses.com/activity/p/5230/ Mon, 20 Nov 2017 04:19:43 -0500 High severity risks are unacceptable because they can cause severe harm to patients. Avoidance or mitigation would be good for high severity risks. Considering risks are high, To avoid them or to eliminate them is a good option rather than taking any chances. Mitigation or acceptance could be choosen for low severity risks because its okay to…[Read more]

]]> 0 b2c41c04b14fe3be4a7f5d9bf68f8b0e https://medicaldevicecourses.com/activity/p/5070/ Mon, 13 Nov 2017 03:56:59 -0500 Devices which are used outside the body and which does not need clinical/ preclinical trials does not possess severe risks to patient. Few examples include sthethoscope, surgical tape, colostomy bags etc. These devices does not pose risks to patients and only verification and validation is sufficient rather than preclinical/clinical trials.

]]> 0