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su65 replied to the topic "Restrictions for physician's gifts" – 6 years ago
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»
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su65 replied to the topic "NDA vs Patents" – 6 years ago
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»
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su65 replied to the topic "Written Agreement v/s Verbal Agreement" – 6 years ago
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»
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su65 replied to the topic "Organization types of medical devices?" – 6 years ago
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»
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su65 replied to the topic "Matrix Organization- Conflict" – 6 years ago
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»
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su65 replied to the topic "Effective way to culminate inter department silos" – 6 years ago
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»
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su65 replied to the topic "Risk Management Mistakes" – 6 years ago
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»
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su65 replied to the topic "Risk management and Labels" – 6 years ago
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»
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su65 replied to the topic "Manage Risk" – 6 years ago
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»
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su65 replied to the topic "Design Verification & Validation vs Clinical & Pre-Clinical Trials" – 6 years ago
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»
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su65 replied to the topic "Design Verification & Validation vs Clinical & Pre-Clinical Trials" – 6 years ago
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»
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su65 replied to the topic "Factors to Consider While making Gantt Chart" – 6 years ago
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»
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su65 replied to the topic "Important Part of DDP" – 6 years ago
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»
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su65 replied to the topic "Important Part of DDP" – 6 years ago
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»
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su65 replied to the topic "Consequences Of Insufficient Design Controls" – 6 years ago
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»
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su65 replied to the topic "Design Controls in the other countries" – 6 years ago
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»
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su65 replied to the topic "Clinical Studies" – 6 years ago
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»
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su65 replied to the topic "Clinical Trial Roles" – 6 years ago
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»
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su65 replied to the topic "Discussion Topic: Having a "clinical background"" – 6 years ago
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»
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su65 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" – 6 years ago
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»
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