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an83 replied to the topic "Benefits of Consulting Experience as a Recent Graduate" – 1 year, 4 months ago
In considering the viability of consulting as a career path for recent graduates, it’s important to weigh the unique advantages and considerations it presents, especially in a competitive job market. Consulting offers flexibility, diverse learning opportunities, and potential pathways to… Read more»
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an83 replied to the topic "Restrictions for physician's gifts" – 1 year, 4 months ago
The ethical guidelines governing gifts and incentives in the medical industry, particularly the $100 cap on gifts to physicians and the prohibition of covering expenses for a physician’s spouse, may initially appear overly restrictive. However, these rules serve a vital… Read more»
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an83 replied to the topic "Verbal Contracts" – 1 year, 4 months ago
In the medical device industry, ensuring adherence to verbal contracts involves a combination of meticulous documentation and ethical practices. One key strategy is the detailed recording of conversations, where notes are taken during or right after discussions; however, if actual… Read more»
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an83 replied to the topic "Malsow's law in organization" – 1 year, 4 months ago
I really like your analogy to Maslow’s Hierarchy of Needs. In the responses so far, there seems to be a divergence between the needs of the company and the needs of the employees. There seems to be good discussion addressing… Read more»
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an83 replied to the topic "Forming a Project Team" – 1 year, 4 months ago
There are pros and cons to working with those familiar to you. One pro is that the forming and storming phases of project team formation are much more streamlined, especially if one is familiar with the working styles of other… Read more»
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an83 replied to the topic "Desicion made by one person" – 1 year, 4 months ago
To see the pros in decisions made by one person is an interesting concept. In school, especially in the American standard of education, we are taught, both in the form of group projects and 20th century history lessons, that decisions… Read more»
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an83 replied to the topic "Expense of Regulations" – 1 year, 4 months ago
Your observations about the costs associated with accessing various standards and regulations in the medical device market are indeed thought-provoking. The primary reason these regulations carry a significant cost is that regulatory compliance has evolved into a complex and specialized… Read more»
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an83 replied to the topic "To risk manage or not to risk manage?" – 1 year, 4 months ago
Risk management is an essential part of the planning phase, embodying the principle that “a stitch in time saves nine.” By identifying and addressing potential risks early, it prevents minor issues from escalating into major setbacks, thereby saving time and… Read more»
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an83 replied to the topic "Risk Acceptance" – 1 year, 4 months ago
Risk acceptance does indeed imply a higher probability of encountering the risk, as it involves acknowledging the risk without taking any specific action to avoid or mitigate it. This approach is typically chosen when the cost or effort of other… Read more»
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an83 replied to the topic "Design Matrix Content" – 1 year, 4 months ago
A basic overview of the design process may be obtained from a Design Matrix that includes columns for inputs, requirements, validation, and verification; however, for more complicated projects, this may not be sufficient. Its effectiveness may be significantly increased by… Read more»
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an83 replied to the topic "Gantt Chart Thought Process and Considerations" – 1 year, 4 months ago
When creating a Gantt chart for project management, start by defining the project scope and objectives to identify all necessary tasks. Break the project into smaller tasks, and establish their sequence and dependencies, recognizing which tasks are sequential and which… Read more»
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an83 replied to the topic "Document Corrections" – 1 year, 4 months ago
Issuing a Design Change Request is the normal remedial action when problems are found in design documents, such as the Design Input Document (DID) or the Design Specification Document (DSD). This procedure starts with locating the mistake and ends with… Read more»
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an83 replied to the topic "Minutes for meetings" – 1 year, 5 months ago
Meeting minutes are an essential tool for effective team communication, serving as a detailed record that enhances accountability, provides clarity, ensures continuity, and meets legal requirements. They not only capture decisions and assignments, fostering accountability, but also act as a… Read more»
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an83 replied to the topic "Validation vs Verification" – 1 year, 5 months ago
In product development, verification and validation serve as critical, distinct checkpoints to ensure quality and efficacy. Verification addresses the question, “Are we building the product right?” by confirming that the product adheres to specific design requirements through tests, inspections, and… Read more»
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an83 replied to the topic "Initializing Design Controls" – 1 year, 5 months ago
Implementing a robust Risk Management Process is paramount when redesigning design controls in a medical device company, as it ensures compliance with regulations like ISO 14971 and fortifies the Quality Management System. This process, which is integral to product safety… Read more»
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an83 replied to the topic "Incentives for Clinical Trial Participants" – 1 year, 5 months ago
Honestly, money seems to be the greatest form of financial compensation that could be offered. Many people above have suggested offering healthcare services; however, in the United States, that is functionally equivalent to financial compensation, which would likely go towards… Read more»
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an83 replied to the topic "Retrospective studies" – 1 year, 5 months ago
My aim is to look into the applications of artificial intelligence in radiology. Therefore, for my career path, the best type of clinical study would undoubtedly be a Retrospective Study. Radiology, as a field, has amassed a vast amount of… Read more»
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an83 replied to the topic "Placebo Effect" – 1 year, 5 months ago
I would disagree that the placebo effect can have negative effects on a clinical trial. This is because in a clinical trial, there is a difference between a sign and a symptom. Signs are results of illness that are visible… Read more»
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an83 replied to the topic "Marketing and Advertising: Can the two collide?" – 1 year, 5 months ago
From my perspective, while I don’t have a background in journalism or creating media content, I’ve observed the trends in marketing and advertising across various channels. It’s evident that companies, especially in the biotechnology and medical device sectors, strategically place… Read more»
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an83 replied to the topic "Transition from Engineering to sales or marketing?" – 1 year, 5 months ago
Engineering majors follow the opposite trend of communications majors. While communications majors are most hireable right after they finish college, engineering majors are most valuable after years of experience. However, that experience is not always directly transferable after years of… Read more»
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