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Forum Replies Created

RE: Ethical Challenges of AI in Clinical Trials

Artificial intelligence has been up on the rise as of recent years, but it seems to be slowly taking over this past year. I have not seen this much use of AI until this year. AI can be used to help st...

In forum Clinical Research Basics

3 months ago
RE: Benefits for Patients in Clinical Research

Clinical experiments require human testing and this is usually done after preclinical trials have passed in animals and are deemed safe to perform on human testing. It is more involved than animal tes...

In forum Clinical Research Basics

3 months ago
RE: Placebo Effect

Reading all of the responses, I would like to disagree that the placebo effect cannot have any negative effects on a clinical trial. I think that placebo effects can skew data results in pharmaceutica...

In forum Clinical Research Basics

3 months ago
RE: External Environment Factors

Generally, almost every company is going to be affected by external factors like the weather, politics, economy, competitors, and collaborators. There is really no escape as external factors are facto...

In forum Marketing and Sales

4 months ago
RE: Branding as an Engineer

People who are designated in branding control the product’s image. I feel like I may be able to do a good enough job in that department. I do not have much confidence in my skills to say that I will b...

In forum Marketing and Sales

4 months ago
RE: Building marketing trust in medical devices: healthcare providers vs patients

In terms of marketing, we all have seen those drug commercials on TV where it is usually a patient describing their story and how this medication saved their lives, while the doctor on screen agrees a...

In forum Marketing and Sales

4 months ago
RE: Factors going into Buisness

First and foremost, I think it would depend on the business you want to build, the location, the size, and the need for your product or services. For example, if you are going into the food business, ...

In forum Business 101

4 months ago
RE: Differences in team dynamics and leadership styles between corporations and research labs

In research labs, it seems like creativity and productivity is easier to achieve than in corporations. For example, research students, facility mentors, or researchers in general have a common goal th...

In forum Business 101

4 months ago
RE: LLP vs LLC

I believe that many business owners or those that go into entrepreneurship prefer an LLC over an LLP due to the flexibility over ownership with the business. Typically, LLCs are easier to form than LL...

In forum Business 101

4 months ago
RE: organizational skills for QC

I do not have much experience with the industry and medical devices for quality control, but I do have experience with our quality control department at a laboratory with how they maintain accurate re...

In forum Quality Control and Quality Assurance

4 months ago
RE: FDA Advisory Panel Members with QC/QA Background

Every user has provided good points on who would be beneficial to be a panelist in a FDA advisory panel. I agree with torikul as they have highlighted generally the most important people that should b...

In forum Quality Control and Quality Assurance

4 months ago
RE: Most effective ways to manage risk in the context of Quality Assurance for high-risk medical devices (Class III)

In this week’s lesson, we have learned that quality assurance makes sure that all of the systems, structures, reviews, and evaluations meet the requirements to ensure the product or services are appro...

In forum Quality Control and Quality Assurance

4 months ago
RE: Punishment for Failing FDA Audits

Even though minor errors are present, it is still a mistake either way since it is, for example, a class III medical device. No one wants there to be an error once everything has been set in stone and...

In forum Regulatory Basics for Medical Devices

4 months ago
RE: Product Labeling

To me, there is someone that should be held accountable and responsible for the product mishap. I would choose not to buy that product. I agree with what vbp098 said. Most customers would notice the d...

In forum Regulatory Basics for Medical Devices

4 months ago
RE: Switching to a Regulatory Career

I would like to say that I am in the beginning phase of my career. I do not think I would switch from the engineering role to the regulatory role. Honestly I have not considered a more regulatory role...

In forum Regulatory Basics for Medical Devices

4 months ago
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