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mb698 replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 7 months ago
Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical device. It is important because the product designed should be safe to efficient to meet the consumers need and wants. Design control is…[Read more]
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mb698 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 6 years, 7 months ago
Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical devices. Design control is one of the most important thing in medical device since the design of the product can lower the profit of the…[Read more]
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mb698 replied to the topic Placebo-controlled trials: Are they ethical? Are they necessary ? in the forum Clinical Research Basics 6 years, 7 months ago
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a placebo treatment which is specifically designed to have no real effect. I think Placebo Controlled Trails (PCT) is important, necessary and its ethical…[Read more]
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mb698 replied to the topic Double Blind Vs Single blind Study in the forum Clinical Research Basics 6 years, 7 months ago
A single blind experiment only the participants does not know whether they are part of the treatment or the control group, whereas in a double-blind experiment both the participant and the experimenter are kept in the dark as to who is in the treatment and who is in the group. Double blind study serves as a standard by which all the studies are…[Read more]
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mb698 replied to the topic Clinical Studies in the forum Clinical Research Basics 6 years, 7 months ago
Clinical studies is the study of health and illness of the people. It’s a way learn how to prevent, diagnose and treat illness. Clinical studies describe different elements of scientific investigation. It observes people in normal settings. Researcher gather information, group volunteers according to the broad characteristics and compares the c…[Read more]
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mb698 replied to the topic Medical Device SWOT Analysis in the forum Marketing and Sales 6 years, 7 months ago
SWOT analysis is a useful technique to understand the strength and weakness of the person or the organization and to identify the opportunities and threats that an organization or the person faces. GE Healthcare is a manufacturer and distributor of diagnostic imaging agents and radiopharmaceuticals for imaging modalities that are used in medical…[Read more]
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mb698 replied to the topic Marketing Strategy in the forum Marketing and Sales 6 years, 7 months ago
GE healthcare CT scan uses marketing tools around the globe, consolidating more than 100 systems into just three: Zinc Ahead, Salesforce, and Marketo. Previously, it took a few months for GE Healthcare to get approval on content. The company uses the medical compliance software, Zinc Ahead, to review and approve content, curtailing the process by…[Read more]
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mb698 replied to the topic Discussion Topic: Emotional Intelligence and its affect on sales in the forum Marketing and Sales 6 years, 7 months ago
Emotional intelligence (EI) refers to having the ability to recognize and understand emotions and their impact on behavior and attitudes. Those who have a high degree of EI are in tune with both their own emotions and the emotions of other people with whom they come in contact. EI involves being sensitive to and perceptive of other people’s…[Read more]
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mb698 replied to the topic Public vs. Private Companies in the forum Business 101 6 years, 8 months ago
The private companies are owned by the founder of the company or a group of private investors. The profit is shared with the employees by profit sharing or stock appreciation rights. Pros of private companies is that the company must who the investors are. There is no requirement of the disclosures. Cons of Private companies are they must find…[Read more]
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mb698 replied to the topic Types of Corporations in the forum Business 101 6 years, 8 months ago
Each ownership of the corporations has its advantages and disadvantages. I would prefer to be Limited Liability Corporation (LLC) over the other types of corporations. There are no limited possible owners. The partners can sell shares to raise money, there is limited liability in LLC. LLC are easy to operate, partners can draw money from the…[Read more]
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mb698 replied to the topic Partnership characteristics in the forum Business 101 6 years, 8 months ago
Both Partnership and Sole proprietorship has advantages and disadvantages, but I think Partnership is an advantage for a business over the sole proprietorship since there are two or more number is people who are the owners. The risk is distributed among the partners. Partnership give wider range of expertise for different parts of the business.…[Read more]
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mb698 replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 6 years, 8 months ago
Quality is one of the important factors when it comes to a product or the service. Quality of a product differentiates for all the products and services. Quality control is important since it is essential to build a successful business and satisfies the needs of the customer. Quality control and assurance is an important part of product or medical…[Read more]
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mb698 replied to the topic Your Ideas about Improving Quality Control in the forum Quality Control and Quality Assurance 6 years, 8 months ago
Quality is one of the most important aspects of a company. I think quality can be improved if there is commitment towards the quality of the product or the services and it should be reinforced again and again. Then I think Tracking the mistakes is one of the important aspects for any product and services, for the manufacturers the process of…[Read more]
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mb698 replied to the topic R&D vs Quality in the forum Quality Control and Quality Assurance 6 years, 8 months ago
R&D and quality are the two different departments of the company. R&D helps the business to have a competitive edge over its competitors whereas the quality department ensures that the product or services adhere to a defined set of quality criteria or meets the customers. R&D department which involves developing products or services and to…[Read more]
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mb698 replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
Recall is used when the manufacturer takes a correction or removal action to address a problem with a medical device that violates the FDA rules. Recalls is done when there is any defect in the medical device which could cause the risk to health. There could be many reasons for the recall like inspecting the device for the problems, repairing the…[Read more]
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mb698 replied to the topic Drugs banned in US but not in other countries in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
Oxyphenbutazone is a nonsteroidal anti-inflammatory drug. It was withdrawn from markets worldwide in mid-1980 due to bone marrow suppression and Stevens-Johnson syndrome. It has been used by mouth in rheumatic disorders such as ankylosing spondylitis, osteoarthritis and rheumatoid arthritis but its use is no longer considered as there is risk of…[Read more]
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mb698 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
FDA is the government agency that protects and promotes the public health by regulating food safety, vaccines, medical devices. FDA is strict and puts regulation on the product which to be released into the market. Before the product enters the market, the product needs to go through the FDA regulations which causes delay in the release. FDA…[Read more]
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mb698 replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development 6 years, 8 months ago
Academic research is more flexible in terms of how the procedure is to be followed since there are no such deadlines and the researcher has more control over the time. In academic the funding is public which makes it limited whereas in industry research the funding in private which make it more flexible. In industry research you work with other…[Read more]
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mb698 replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 6 years, 8 months ago
Animal testing helps the researchers and scientists to have improved medicines and treatments which helps in various diseases. It is important for improving the health of the human beings it also helps the safety of the drugs that human being consumed. I think that animal testing is unethical as animals undergoes lot of pain. There are tests done…[Read more]
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mb698 replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 6 years, 8 months ago
Research for future and now both are important working on research for long term is beneficial because it will help the future generations. According to me research which is now can be used and the goals can be accomplished in future. I think that research which is now will benefit the present generation also the future generation with improved…[Read more]
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