Medical Device Courses | Efields30 | Activity

Efields30 posted a new topic "Contract Law components examples" -

Sat, 23 Apr 2022 22:22:11 -0400

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.

Efields30 posted a new topic "Project management" -

Sat, 23 Apr 2022 22:18:00 -0400

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»

Efields30 posted a new topic "Matrix Organization success examples" -

Sat, 23 Apr 2022 22:13:10 -0400

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»

Efields30 posted a new topic "Evaluating in the RM process" -

Sun, 17 Apr 2022 01:54:10 -0400

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»

Efields30 posted a new topic "Risk Management Process" -

Sun, 17 Apr 2022 01:44:10 -0400

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»

Efields30 posted a new topic "Hazard, Hazardous, Harm" -

Sun, 17 Apr 2022 01:24:34 -0400

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»

Efields30 posted a new topic "Design Specification document" -

Sun, 10 Apr 2022 02:16:03 -0400

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»

Efields30 posted a new topic "Project Proposal" -

Sun, 10 Apr 2022 02:11:59 -0400

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»

Efields30 posted a new topic "Design Controls Component" -

Sun, 10 Apr 2022 02:05:42 -0400

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»

Efields30 posted a new topic "Types of clinical studies" -

Sun, 03 Apr 2022 02:30:50 -0400

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.

Efields30 posted a new topic "FDA GCP's" -

Sun, 03 Apr 2022 02:05:24 -0400

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»

Efields30 posted a new topic "Tests and treatments involved in clinical trials" -

Sun, 03 Apr 2022 01:58:00 -0400

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»

Efields30 posted a new topic "LLP’s responsibility" -

Sat, 26 Mar 2022 01:55:43 -0400

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.

Efields30 posted a new topic "Scenarios if internal & external environments" -

Sat, 26 Mar 2022 01:54:53 -0400

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»

Efields30 posted a new topic "Market growth rate" -

Sat, 26 Mar 2022 01:53:52 -0400

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»

Efields30 posted a new topic "Examples and ways to improve quality assurance" -

Sun, 20 Mar 2022 03:09:50 -0400

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»

Efields30 posted a new topic "FDA regulation example" -

Sun, 20 Mar 2022 03:01:02 -0400

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»

Efields30 posted a new topic "Disease Outbreaks" -

Sun, 20 Mar 2022 02:51:46 -0400

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»

Efields30 posted a new topic "Species in Animal Testing" -

Sun, 13 Mar 2022 03:32:45 -0400

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»

Efields30 posted a new topic "Stability testing importance" -

Sun, 13 Mar 2022 03:31:46 -0400

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»

Efields30 posted a new topic "Difference in Biocompatibility testing" -

Sun, 13 Mar 2022 03:29:11 -0400

This week we learned about the importance of biocompatibility testing and how this testing assess the compatibility of medical devices with a biological system. This test must be done for a material or device before clinical studies can occur. Compare… Read more»

Efields30 posted a new topic "Academia or Industry Preference?" -

Sat, 05 Mar 2022 18:40:54 -0500

Efields30 posted a new topic "Regulatory Affairs identified problems" -

Sat, 05 Mar 2022 18:40:53 -0500

Efields30 posted a new topic "PM cycle" -

Sat, 05 Mar 2022 18:40:52 -0500

Efields30 posted a new topic "PM stakeholders benefits" -

Sat, 05 Mar 2022 18:40:51 -0500

Efields30 posted a new topic "Benefits of an academia relationship" -

Sat, 05 Mar 2022 18:40:50 -0500

Efields30 posted a new topic "PM certification benefits" -

Sat, 05 Mar 2022 18:40:49 -0500