amd97

Forum Replies Created

RE: Distinguishing Between Hazards and Hazardous Situations in Risk Evaluation

It is important to consider the hazard and hazardous situation as aspects to be evaluated separately because of the difference between how a person is. Hazard is considered the source of harm where th...

In forum Risk Analysis for Medical Devices

5 days ago
RE: Two Types of Risk

Internal risks are risks which are controlled and start from the inside of a company while external risks are risks which are not as controlled and start from the outside of a company. With internal r...

In forum Risk Analysis for Medical Devices

6 days ago
RE: Risk Management

Some critical characteristics of the risk profile of a medical device includes the devices intended use, the class of the device (I, II, or III), which also represents the potential harm and invasiven...

In forum Risk Analysis for Medical Devices

6 days ago
RE: Design Verification Ethics

I myself have not seen any companies that do this because I have yet to work in industry but I do know that this is considered to be very unethical. The verification process when working on a design i...

In forum Introduction to Design Controls

2 weeks ago
RE: How Many Design Reviews Are Enough?

Teams can decide when they have done enough reviews after meeting multiple times throughout the design process course. By doing this, the team can have time and opportunities to go through all the ris...

In forum Introduction to Design Controls

2 weeks ago
RE: Validation vs Verification

I have not worked in industry yet, but I learned a lot about the difference between verification and validation through the FDA course I took last semester then again during this course. I also expec...

In forum Introduction to Design Controls

2 weeks ago
RE: User Needs vs. Business Goals — Who Wins in Design?

A team should really aim towards making their user needs balance and come hand in hand with a businesses goal. The point of being the engineering behind the product and project is to meet the business...

In forum Introduction to Design Controls

3 weeks ago
RE: Verification vs. Validation — Do We Really Need Both?

It is necessary to have both the verification and validation processes separate because they are intended for two different things. Validation ensures that the device is the correct product for the us...

In forum Introduction to Design Controls

3 weeks ago
RE: Minutes for meetings

I believe that when it comes to taking meeting minutes its essential that way, when referring back to what was said in the meeting, it is clear and concise. It also helps when needing to gain an under...

In forum Introduction to Design Controls

3 weeks ago
RE: WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?

The purpose of clinical testing is to decide if a drug is safe and effective enough to treat a certain condition. Drugs function by affecting biological functions within the body. Clinically tested dr...

In forum Clinical Research Basics

4 weeks ago
RE: Diversity and Inclusion in Clinical Trials

By finding multiple volunteers from all different backgrounds and making enrollment goals meet these standards, companies can ensure that their study patient group is as needed and expected. By using ...

In forum Clinical Research Basics

4 weeks ago
RE: Placebo Effect

When comparing results from a group that receive test drugs and a group that are given the placebo, the placebo effect can be differentiated. It is happens to be that the two groups exemplify positive...

In forum Clinical Research Basics

4 weeks ago
RE: Who Are You Selling To?

When developing a company to manufacturing dental tools, I would sell them to dentists themselves, dental retailers, and dental clinics/ offices. Because dentists are the primary users, selling to the...

In forum Marketing and Sales

1 month ago
RE: Brand Coloring

I have noticed that different industries typically lean towards certain colors in their branding. For example, green is usually used for biological, natural, and health brands while blue is used for ...

In forum Marketing and Sales

1 month ago
RE: When Does a Surgeon Become a Brand Ambassador Ethically?

Physicians should be compensated for their time and skills when it comes to testing or developing new and upcoming devices but not regarding the number of devices sold or referencing it to be used. T...

In forum Marketing and Sales

1 month ago
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