Contract law consists of offer & acceptance, Consideration, Intention to create legal relations, capacity, and formalities. Describe an example of each of these components and why it is important.  

In project management it is important to develop a project management plan, Risk management plan, and some type of design input document. In a design development plan what should it contain and why is it important to the project to…   Read more»

In matrix organization project managers and functional heads may or may not have a lot of power. It depends on the “Strong Matrix” or “Weak Matrix” on whether an outcome would be successful. Give two scenarios in which a project…   Read more»

During the risk management process you are starting an analysis to categorize the risks and after you are estimating their probabilities and severities. List three(3) potential risk using a Automated external defibrillator (AED) and describe what will take place in…   Read more»

During the risk management process it is important to implement a risk management plan and assign a risk management team. Analyzing the risk helps you decide whether you should continue the production with the risk or end the operation overall….   Read more»

This week we reviewed the general concept of hazards, hazardous situations, and the effect of being harmed. An example would be a biohazard that someone is exposed to and contracting a specific infection or disease. Describe a scenario listing a…   Read more»

A design specification is a “detailed document providing a list of points regarding a product or process”. This includes required dimensions, environmental factors, ergonomic factors, aesthetic factors, and maintenance. Provide an example of a product and its components that would…   Read more»

The project proposal is the initiation of the product and its description of the business need. It is a broad description of the basic time line or this device or medication and is an overall outline of the fit to…   Read more»

This week when learning about design controls we viewed the nine parts within this process. Planning, Input, Output, review, verification, validation, transfer, design changes, and design history files are all important components to ensure safe and productive measures are in…   Read more»

This week we learned multiple types of clinical study, Retrospective, Blinded, Randomized, etc. Research a clinical study you are interested in and describe which type of clinical study it is.

Good clinical practices are a guideline to ensure a safe and effective outcome of all research experiments. The FDA give guidance documents such as information sheets for IRB’s and investigators. Identify a FDA GCP example or document and describe the…   Read more»

We learned this week preforming clinical trials are risky and important involving testing on humans. More precautious and approvals are necessary for this study, along with tests and treatments. Research a specific test or treatment in clinical research and describe…   Read more»

There are many LLP’s in the world. They have many advantages and disadvantages but still are manageable if operated correctly. Research an LLP and discuss its business and duties.

Marketing has many interactions within their external and internal environments. We learned that external could be the weather , politics, or the environment while internal refers to competitors and collaborators. Describe a scenario that is an example of internal and…   Read more»

Some good examples of markets that are currently in the growth stage include mobile applications, solar power, and Telehealth services. Each of these markets has seen total sales increase by at least 20% per year for at least the last…   Read more»

Quality Assurance is a way of preventing mistakes and issues within manufacturing environments. Describe ways to prevent and ensure manufacturing safety. In addition look up a issue that has happened in manufacturing environments and add solutions for an issues that…   Read more»

The FDA has created many regulation agencies to monitor medical devices, biologics , and drugs. CDRH: Reviews and approves medical devices •CDER: Reviews and approves prescription, OTC, and generic drugs •CBER – Reviews and approves biologics, donor screening, and blood…   Read more»

In the PowerPoint discussion regulatory basis for medical devices it described how the tetanus Tetanus outbreak traced to diptheria antitoxin  was the reason the FDA fully intervened and began this increased regulatory environment, what disease outbreak can you think of that…   Read more»

Animal testing is essential in scientific research because it seeks to analyze the variables that affect behavior or biological system under a study. The main pitfall in animal testing is suppliers running out of animals, but if suppliers have enough…   Read more»

Stability Testing is an essential process for each component of a medical device. It determines how long a product remains safe and effective at specific intervals. After multiple runs of testing is cleared final device stability is now ready. What…   Read more»