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mbonds replied to the topic "Restrictions for physician's gifts" – 2 years ago
I definitely think that it is a little too restricted, but usually a lot of the time doctors do not even accept any gifts or they pay it forward. Doctors are a lot more laid back in my opinion when… Read more»
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mbonds replied to the topic "Forming a Project Team" – 2 years ago
Essentially having or getting together a great reliable team is extremely important for any type of project. I think that I would rather work with people that are knowledgeable on the specific topic rather than peripheral I simply like. Many… Read more»
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mbonds replied to the topic "Upper vs Middle Management." – 2 years ago
I also believe that I can do both upper and middle management. Middle managers act as go-betweens for executives and lower-level staff. They are on the front lines of putting senior management’s ideas into action through the collaboration of junior employees… Read more»
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mbonds liked forum post "Benefits of post-market surveillance" – 2 years ago
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mbonds replied to the topic "Dealing with risk" – 2 years ago
Researchers charged with developing new medical devices have the difficult issue of making a medical gadget safe for human usage. Risk management entails identifying, comprehending, controlling, and preventing failures that can result in dangers when people use medical technology. The… Read more»
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mbonds replied to the topic "Benefits of post-market surveillance" – 2 years ago
I really like this question as I actually recently applied for a job in this sector! I’m my opinion post market surveillance essentially holds the company together and ensures that the products or product of the company excels expectations, meets… Read more»
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mbonds replied to the topic "Risk management and Labels" – 2 years ago
After the product has been manufactured and the company has done everything possible, it is up to the consumer to use the product as directed. The manufacturer should have clearly written labeling and directions on how to use the medication,… Read more»
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mbonds replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" – 2 years ago
Design verification is the process of ensuring that your design outputs correspond to your design inputs. Again, design verification is defined by the FDA as “confirmation by examination and provision of objective evidence that specified requirements have been met.” Design… Read more»
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mbonds replied to the topic "Design Controls: What do you deem most important?" – 2 years ago
The design must be verified and validated after all User Needs, design inputs, and design outputs have been generated. This is frequently referred to as “V&V.” But what exactly does it mean? At this point, you’ll need to establish: You… Read more»
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mbonds replied to the topic "What are Design Controls?" – 2 years ago
The FDA requires design controls to facilitate a structured design and development process for medical devices. There are numerous checkpoints in place to ensure that the device is safe and effective when it is released to the public. Compliance with… Read more»
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mbonds replied to the topic "Clinical trials for Alzheimer’s disease" – 2 years ago
The secret to treating Alzheimer’s disease (AD) may lie in a medicine that has been promoted as a way to prolong life. Scientists have looked into rapamycin as a potential cure for Alzheimer’s disease and are now doing research. An… Read more»
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mbonds replied to the topic "Incentives for Clinical Trial Participants" – 2 years, 1 month ago
Rewards given to subjects in exchange for their involvement in a study are known as research incentives. Research incentives have been shown to be successful in persuading people to take part in studies, which contributes to the production of high-quality,… Read more»
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mbonds replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 2 years, 1 month ago
Henrietta Lacks was extremely influential to the medical community. HeLa cells have been crucial in understanding human diseases, particularly cancer, and mapping genes. The creation of the first polio vaccine, however, may have been HeLa cells’ most important use. The… Read more»
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mbonds replied to the topic "Discussion Topic: The Fifth "P" of Marketing" – 2 years, 1 month ago
In this scenario, he owner is entirely responsible for the operation of the business and for determining what is and is not permitted. The proprietor is free to alter anything he thinks will benefit the expansion of his company. Sadly,… Read more»
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mbonds replied to the topic "Digital Marketing" – 2 years, 1 month ago
The digital era has changed how companies promote their goods. Because the playing field has been completely changed, businesses must now customize their customer-reach strategies. Although it has increased the number of new businesses, in many ways it has also… Read more»
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mbonds replied to the topic "Accepting job based on company." – 2 years, 1 month ago
I personally think that early on in your career (for example recent graduates) you have the option to be more open to working anywhere that will give you an exponential amount of experience that will eventually take you extremely far… Read more»
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mbonds replied to the topic "FDA Approval During Public Health Emergencies" – 2 years, 1 month ago
The FDA’s responsibility is to guarantee that medical products adhere to exacting safety and efficacy standards. This process, known as “full approval,” can take years. The FDA continues to maintain its strict standards even though that period of time is… Read more»
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mbonds replied to the topic "What are some ways Document Control can improve?" – 2 years, 1 month ago
Document control is a crucial component of an efficient internal control system, which is necessary for compliance with regulations like ISO 9001, ISO 13485, IATF 16949, etc. When done manually, document control includes maintaining relevant (i.e., current) versions of policies… Read more»
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mbonds replied to the topic "Cutting Corners in Research" – 2 years, 1 month ago
In general with anything in life cutting corners and taking shortcuts can lead to serious consequences. The research process relies on trust, and trust is essential for maintaining research integrity. Having trust in each other’s work is imperative, and researchers… Read more»
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mbonds replied to the topic "Discussion Topic: Biomaterial Selection" – 2 years, 1 month ago
The selection of a biomaterial is crucial for medical device project management. Some factors to consider when selecting a biomaterial are cost, biocompatibility, and accessibility just to name a few. With cost, we have to keep in mind the upfront… Read more»
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