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Forum Replies Created

Researches market Is there a need?

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 ...

In forum Marketing and Sales

4 years ago
RE: Marketing Strategy

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 ...

In forum Marketing and Sales

4 years ago
RE: Form 483

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...

In forum Quality Control and Quality Assurance

4 years ago
RE: Risk Management Tools

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 alw...

In forum Risk Analysis for Medical Devices

4 years ago
Implementing a risk management plan

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 f...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Risk Management - Identification

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 ...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Recent Examples of Kickback Allegations

"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...

In forum Consultants and Legal Basics

4 years ago
RE: Malsow's law in organization

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 hi...

In forum Organizational Development in Device Companies

4 years ago
RE: Restrictions for physician's gifts

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 ...

In forum Consultants and Legal Basics

4 years ago
RE: Non for profits

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 in...

In forum Business 101

4 years ago
RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

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 the...

In forum Clinical Research Basics

4 years ago
RE: Informed consent: What if Henrietta Lacks checked No for research use?

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...

In forum Clinical Research Basics

4 years ago
RE: Right to Try Law

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 ...

In forum Clinical Research Basics

4 years ago
RE: Discussion Topic: Quality Assurance vs. Quality Control

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 ...

In forum Quality Control and Quality Assurance

4 years ago
FDA's Quality System Regulation

What is the relationship between FDA's Quality System Regulation forDevices, Part 820, and ISO 9001:2000?

In forum Regulatory Basics for Medical Devices

4 years ago
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