yroberts

Forum Replies Created

RE: Design Control Experience

I've had experience with design control during my undergrad capstone. I got my B.S. in mechatronics engineering and the capstone had to be electronic with other guidelines. We didn't do the specified ...

In forum Introduction to Design Controls

4 years ago
RE: Validation Types

I've been through a process validation before as an Engineering intern. Process validation is the gathering and assessment of data from the process design stage through production to produce scientifi...

In forum Introduction to Design Controls

4 years ago
RE: Design Controls: What do you deem most important?

I think the required documentation for design control is most important. Revised design control documentation serves as a valuable source of truth for the project. Recording everything in one documen...

In forum Introduction to Design Controls

4 years ago
RE: What is risk control? What are some examples of risk control measures taken?

Risk control should form part of the company`s broader health and safety plan providing a method to identify, control, and reduce the risks present in the workplace. The control of workplace risk is a...

In forum Risk Analysis for Medical Devices

4 years ago
RE: What is Risk-benefit analysis ?

One factor is the likelihood that the patient will receive one or more benefits — using the information supplied, it is occasionally feasible to forecast which patients would benefit. It's also feasib...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Two Types of Risk

Internal risk includes personnel management concerns such as labor shortages or low morale, as well as technology difficulties such as outdated software. External risks include economic slowdowns, whi...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Organization types of medical devices?

If I were to create a medical device firm, I believe I would do so as a project-based company at first. PBOs are more concerned with project outcomes than with organizational structure. In compared to...

In forum Organizational Development in Device Companies

4 years ago
RE: project management: organization structure

In a functional organization, projects that exist within a single functional division generate no organizational issues. But projects that extend across functional divisions are demanding to manage. T...

In forum Organizational Development in Device Companies

4 years ago
RE: Contract Laws

I work for Coca-Cola which is now operating in more than 200 countries and producing nearly 500 brands. From a legal and management standpoint, the Coca-Cola company is not a single organization, and ...

In forum Consultants and Legal Basics

4 years ago
Clinical Trial Phase 2 Observations

The researchers will choose a few patients to test the impact of the new medications. Researchers learn about the effects of new medications by studying the reactions of these few people in four phase...

In forum Clinical Research Basics

4 years ago
Double Blind Experiment for Fibroids

The double-blind experiment is a technique used to increase internal validity. Therefore, we do not provide any information about the experiments to the participants or the experimenter. You are parti...

In forum Clinical Research Basics

4 years ago
Good Clinical Practices within Job Roles

On any job search engine, search GCP. Select and define a role here. What are some of the benefits of GCP involved with the job role you selected? Does the job also include clinical research in the de...

In forum Clinical Research Basics

4 years ago
Who Are You Selling To?

You are currently developing a company to manufacturer dental tools. Who are you planning to sale to? (Physician, Hospital, Retailer) Explain your answer.

In forum Marketing and Sales

4 years ago
SWOT Analysis for Medical Device Start-Up

Your client is a medical device start-up developing a internal stent. In order to market this device in the US, the client needs your help with a “SWOT” analysis. Develop a short, basic analysis brief...

In forum Marketing and Sales

4 years ago
Comparing Medical Device Businesses

Research two businesses currently supplying medical devices on the market. Describe how they defer from each other including type of corporation, size, and finances. Also describe a similarity like ty...

In forum Business 101

4 years ago
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