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astone46 replied to the topic "Advice before signing an NDA" – 1 year, 11 months ago
If I were to start up a medical device company that operates worldwide, I would consider a matrix organizational structure. This structure allows for the efficient management of projects while also maintaining functional departments that can oversee operations globally. A… Read more»
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astone46 replied to the topic "Advice before signing an NDA" – 1 year, 11 months ago
If you are asked to sign a non-disclosure agreement (NDA), it is important to carefully review the terms of the agreement before signing. Seek legal advice if you do not understand any aspect of the agreement. Consider the scope of… Read more»
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astone46 replied to the topic "Organization Type vs. Effectiveness" – 1 year, 11 months ago
The choice of organizational structure depends on various factors such as the nature of the work, the size of the organization, and the skills of the employees. The three most commonly used structures are functional, matrix, and project-based. A functional… Read more»
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astone46 replied to the topic "Manage Risk" – 1 year, 11 months ago
If a risk has a low severity level, the best option would be to accept it, as the cost and effort required to mitigate or avoid the risk may be greater than the potential harm caused by the risk. For… Read more»
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astone46 replied to the topic "Benefits of post-market surveillance" – 1 year, 11 months ago
Post-market surveillance is critical for ensuring that medical devices are safe and effective for patients. However, there are other benefits to post-market surveillance beyond safety and efficacy. It can help companies identify potential market opportunities and gather feedback on device… Read more»
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astone46 replied to the topic "How to run a risk management meeting ?" – 1 year, 11 months ago
Running a risk management meeting is a critical step in ensuring that potential risks are identified and mitigated in medical device development. To run an effective risk management meeting, it is important to establish clear goals and objectives, define the… Read more»
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astone46 replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" – 1 year, 11 months ago
Verification is a critical aspect of medical device development as it ensures that the device is designed to meet its intended use and requirements. Verification involves testing and analyzing the device design at each stage of development, ensuring that it… Read more»
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astone46 replied to the topic "Design Controls: What do you deem most important?" – 1 year, 11 months ago
it is widely agreed and I agree that the most important aspect of Design Controls in the medical device development process is the documentation of each stage of the design process, as well as the verification and validation of the… Read more»
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astone46 replied to the topic "Consequences Of Insufficient Design Controls" – 1 year, 11 months ago
Design control is crucial in ensuring that medical devices are safe and effective, and its benefits cannot be overstated. However, issues may arise when the design control process is not used sufficiently or is not followed correctly. For example, inadequate… Read more»
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astone46 replied to the topic "Clinical Trials for Today's Vaccine" – 2 years ago
The idea that American mRNA strands have been more modified over time compared to indigenous people is not scientifically supported. However, it is true that genetic diversity can impact vaccine effectiveness, which is why it is important for vaccine trials… Read more»
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astone46 replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" – 2 years ago
The use of placebo-controlled studies in medical research is a topic of ongoing ethical debate. On one hand, placebo controls are often seen as the gold standard in clinical trials because they allow researchers to evaluate the efficacy of a… Read more»
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astone46 replied to the topic "Can Companies Invest in Stock Market?" – 2 years ago
Retained earnings refer to the profits that a company retains after paying dividends to its shareholders. One of the options available to a company is to invest the retained earnings in the market to take advantage of market returns. This… Read more»
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astone46 replied to the topic "Accepting job based on company." – 2 years ago
I don’t think that I would turn down a job based on the type of company it identifies as. As long as the job meets my requirements when it comes to benefits, pay, culture, and growth potential, I am open… Read more»
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astone46 replied to the topic "Marketing vs. Sales" – 2 years ago
Marketing and sales are two critical functions of any business. Both are aimed at generating revenue and increasing customer base, but they differ in their approach and goals. Marketing is the process of promoting and creating brand awarenress through various… Read more»
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astone46 replied to the topic "Animals Used in Animal Testing" – 2 years, 1 month ago
The use of animals for research, education, and testing is an ethical and political contentious topic. Most of the discourse around this problem focuses on humans and animals’ relative moral worth, or moral value. When the needs of people and animals… Read more»
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astone46 replied to the topic "Changing Careers" – 2 years, 1 month ago
I’ve had a variety of experiences as it relates to changing careers. During my undergraduate career, I began as a nursing major and quickly realized that it was not exactly what I wanted to do and more so what my… Read more»
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astone46 replied to the topic "People in a Project" – 2 years, 1 month ago
Hi Leah, Great discussion overall. I can completely relate. I too held positions on various amount of teams as a teenager and throughout college working with my counterparts on executive boards. The connection with a team is very important… Read more»
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astone46 replied to the topic "Importance of people within the Project" – 2 years, 1 month ago
@knm7 I completely agree with you that the most important person on the team is the client. All of the individuals on the team are working towards the betterment and needs of the client. It is similar to the patient… Read more»