-
eowino posted a new topic "Researches market Is there a need?" – 3 years, 9 months ago
It provides great insights into your business and in the broader marketplace. Market research can identify how customers and potential customers might view your business and identify gaps in customer expectations.
-
eowino replied to the topic "Marketing Strategy" – 3 years, 9 months ago
The first device I know of was CPAP Continuous Positive Airway Pressure, The most effective treatment for obstructive sleep apnea; CPAP blows air with continuous pressure down your throat at night to keep your airways open while you. I heard of this device from… Read more»
-
eowino replied to the topic "Form 483" – 3 years, 9 months ago
The Form 483s are available under the Freedom of Information Act but may be redacted to remove non-public information. The FDA usually publishes select 483s on their website at this location: ORA FOIA Electronic Reading Room; you can find of recently issued 483s are… Read more»
-
eowino replied to the topic "Risk Management Tools" – 3 years, 9 months ago
Risk Register Using Risk Register can be effective this is a living document which is updated frequently throughout the life cycle of the project. It will become a part of project documents and is always included in the historical records… Read more»
-
eowino posted a new topic "Implementing a risk management plan" – 3 years, 9 months ago
The process of putting a strategic plan of managing identified threats and exploiting opportunities into action is called the implementation of the risk management plan. Such a process may take many forms. What methods and tools you are going to choose… Read more»
-
eowino replied to the topic "Risk Management – Identification" – 3 years, 9 months ago
There are numerous ways to identify risks, such as brainstorming, the Delphi Technique, Pre-mortem, and the Cause and Effect Diagram. Depending on the nature of your project, project managers may use two or more of these methods during a project…. Read more»
-
eowino replied to the topic "Recent Examples of Kickback Allegations" – 3 years, 9 months ago
“The False Claims Act offers whistleblowers an effective way to expose and stop pharmaceutical and medical kickbacks in the healthcare system. Kickbacks – hidden financial arrangements between doctors and hospitals or other healthcare providers or companies – are one of… Read more»
-
eowino replied to the topic "Malsow's law in organization" – 3 years, 9 months ago
One of the major issues with Maslow’s hierarchy of needs theory is that it cannot be tested empirically. There is no way to measure precisely how satisfied one level of need must be before the next higher need becomes operative…. Read more»
-
eowino replied to the topic "Restrictions for physician's gifts" – 3 years, 9 months ago
I do not believe that it’s too restrictive. I believe these rules were set for a reason. A line has to be drawn somewhere; otherwise, people will always push the boundaries. So it makes sense to make it restrictive so… Read more»
-
eowino replied to the topic "Non for profits" – 3 years, 10 months ago
A nonprofit organization is one that qualifies for tax-exempt status by the IRS because its mission and purpose are to further a social cause and provide a public benefit. Nonprofit organizations include hospitals, universities, national charities and foundations in a market driven my profits… Read more»
-
eowino replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" – 3 years, 10 months ago
As Dr. Simon discussed in the lecture the mind is a powerful thing and sometimes just believing something is work. I think the placebos are important because it helps scientists by contributing to their research. I believe as long as… Read more»
-
eowino replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 3 years, 10 months ago
Informed consent originates from the patient’s right to direct what happens to their body, even though Henrietta Lacks cells have gone on to contribute greatly to science and make a lot of people rich. I still believe ethically that everybody… Read more»
-
eowino replied to the topic "Right to Try Law" – 3 years, 10 months ago
The Right to Try Act, was signed into law May 30, 2018. This law gave patients another way to access treatments that have not been approved yet the patients that are eligible have been diagnosed with life-threatening diseases or conditions… Read more»
-
eowino replied to the topic "Discussion Topic: Quality Assurance vs. Quality Control" – 3 years, 10 months ago
It’s very easy to confuse the two aspects the first Quality control can be defined as “part of quality management focused on fulfilling quality requirements.” While quality assurance relates to how a process is performed or how a product is made, quality control is more the… Read more»
-
eowino posted a new topic "FDA's Quality System Regulation" – 3 years, 10 months ago
What is the relationship between FDA’s Quality System Regulation forDevices, Part 820, and ISO 9001:2000?
-
eowino replied to the topic "R&D vs Quality" – 3 years, 10 months ago
R&D mainly focuses on being able to advance technology to develop a better products for a company while the area of quality makes sure that the product being made will be safe. In the end both sections value the making… Read more»
-
eowino replied to the topic "Academia vs. Industry Research" – 3 years, 10 months ago
Academia research mainly focused is on research and discovery the love of science and learning. However, we see that it is different in industry work that allows their researchers to feel a sense of immediate impact on patient lives by… Read more»
-
eowino posted a new topic "Medical Device Regulations in the U.S." – 3 years, 11 months ago
Currently, the FDA has three medical device classifications and reporting requirements that have become increasingly stringent.
-
eowino replied to the topic "Ethics and Regulation of Medical Device Development and Manufacturing in Times of Crisis" – 3 years, 11 months ago
Concerning devices, controlled studies of devices can be difficult since outcomes can depend on how they will be used, for example, in surgical procedures, which may vary. The device risks may also be long-term, but many studies do not report… Read more»
-
eowino replied to the topic "Professions in Academia and the Industry" – 3 years, 11 months ago
Posted by: @akshayakirithy I would like to work in R&D department of any medical industry. Research is the place where you explore and get new ideas. You can put yourself in to the world of your own creations.Currently I feel… Read more»
- Load More