Learning Outcomes

Steps in Medical Device Marketing

FDA Marketing Pathways for Medical Devices

ISO 13485 vs 21 CFR Part 820

Lesson Summary

This module teaches you about the basic steps of medical device marketing within the US regulatory environment. You will also learn about the marketing pathways as defined by the US FDA and the premarket requirements before submission. The module also highlights the major differences between ISO 13485 and 21 CFR Part 820.

Fundamentals of US FDA Medical Device Submission Process - Course Assessment

This free online course takes you to the path of medical device marketing in compliance with the US FDA regulations.

Fundamentals of US FDA Medical Device Submission Process

The US FDA has enacted several regulations and policies for medical device manufacturers who wish to market their medical devices in the USA. Enrolling in this online course will familiarize you with the basics of this regulation and help you understand different marketing pathways. You will also get a brief orientation of ISO 13485 and 21 CFR Part 820, the standards required to establish a QMS in the medical device manufacturing industry.

The medical device market is one of the world's most highly regularized and stringently controlled. Whether it is manufacturing, marketing, or testing of medical devices, all the processes are subjected to multaiple regulations and laws. Different bodies and institutions around the world enact these laws and regulations. The US FDA (Food and Drug Administration) is one such agency. As a federal agency of the USA, it is responsible for making laws and regulations governing the manufacturing and marketing of these devices.
The course developers at Exoexcellence Consultants have high expertise in the medical device market, especially those in the EU and the US. With this course, they have tried to provide a basic orientation to medical device marketing in the USA. The target audience of this course is medical device manufacturers and regulatory experts in this field. With this unimodular course, they can build their foundations in medical device marketing in the USA. Even if they are veterans in this field, this course will help them revise their basics.
The structure of this course is pretty simple. There are only three topics. These topics discuss the steps involved in medical device marketing in the USA, the marketing pathways for medical devices described by the FDA, and a comparison between ISO 13485 and 12 CFR Part 820. Both are the basic standards requiring medical device manufacturers to establish a QMS. Overall, this course is a helpful resource for anyone looking to penetrate the medical device market of the USA.

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Safeguarding and Reporting

Safeguarding Vulnerable Adults

Impact of Abuse and Trauma

Creating Safe Environments and Policies

Communication, Trust, and Multi-Agency Collaboration

This module will introduce you to various professional safeguarding strategies for protecting children and vulnerable adults. You'll explore the causes and impacts of different forms of abuse and trauma. We'll show you how to create a safe environment for children and vulnerable adults cohesively and protect them from harm.

Safeguarding Children and Vulnerable Adults - Course assessment

Empower yourself to safeguard vulnerable individuals, fostering a secure community with this free online course.

Safeguarding Children and Vulnerable Adults

Have you ever felt a personal calling to make a difference in the lives of others? Have you thought of safeguarding vulnerable individuals? This course explores the various forms of abuse, their immediate and long-term signs and how they impact the lives of vulnerable individuals. Discover how to ensure a safe environment for children and vulnerable adults using collaborative approaches and the fundamental principles of safety and well-being

Topic 1: Introduction to Child Protection

Topic 2: International, Regional and National Legal Framework

Topic 3: Alternative Care and Child Safeguarding

Topic 4 : Monitoring and Evaluation in Child Protection

In this module, you will learn the fundamental concepts, guiding principles, and ethical considerations related to child protection before considering the international, regional, and national legal frameworks. We discuss the current approaches to prevent and respond to child abuse or neglect, including the signs of abuse, neglect, or violence.

Comprehensive Child Protection Training Course - Course Assessment

Learn the skills to prevent and respond to child abuse, neglect, exploitation and violence in this free online course.

Comprehensive Child Protection Training 

This online child protection course equips students with the knowledge and skills to identify, prevent, and respond to child abuse and neglect. You will learn to recognise signs of abuse, understand strategies for prevention and response to violence against children such as INSPIRE, and apply best practices for intervention and support. The course empowers learners to play a critical role in safeguarding children and promoting their well-being.

The Importance of Safe Food Handling - Part 1

The Importance of Safe Food Handling - Part 2

Organized Efforts for Food Safety

The ServSafe Examination

ServSafe Manager Certification - Sample Questions

This module teaches you about the fundamentals of safe food handling and different ways to prevent food contamination. It also talks about the global efforts concerning food safety and the role of the ServSafe certification program. Moreover, you will also be equipped with the essential knowledge to prepare yourself for the ServSafe exam.

Fundamentals of Serving Safe for Food Handlers - Assessment

This course will describe the methods of protecting food from getting contaminated and the basics of the ServSafe exam.

Fundamentals of Serving Safe for Food Handlers

Safe and hygienic food handling is extremely important to prevent contamination and diseases. This holds especially true for the professionals in the culinary sciences and food management field. Through this course, we have emphasized various areas and practices concerned with the safe handling of foods. We have also focused on the global efforts to ensure food safety along with the ServSafe certification and its various aspects.

Topic 1 : WorkSafeBC Regulations

Topic 2 : Responsibilities of Employers and Workers

Topic 3 : Handle Hazardous Materials Safely

Topic 4: Information to Be Disclosed on an SDS

Topic 5: WHMIS Education and Training

Workplace Hazards and WHMIS: A Guide to Safety and Legal Duties - Assessment

This free online course covers the laws and rules that must be complied with to guarantee safe and healthy workplaces.

Workplace Hazards and WHMIS: A Guide to Safety and Legal Duties

Are you aware of the laws protecting you from hazardous substances at work? This course covers essential regulations, including the Workers' Compensation Act, WorkSafeBC policies, and the Workplace Hazardous Materials Information System (WHMIS). Learn about employer and worker responsibilities, safe handling of hazardous materials, and the must-know guidelines that keep workplaces safe. Gain critical knowledge to protect yourself and others.

Introduction to Epilepsy

Diagnosing and Classifying Epilepsy with EEG

This module will demonstrate how to run simulations of six neurophysiological phenomena using simulation software known as MetaNeruon. It will also discuss the neurological conditions underlying epilepsy and how to use an EEG to diagnose this mental disorder.

Understanding Epilepsy - Course Assessment

This free online course takes you through the symptoms, classifications, diagnosis and treatment of epilepsy.

Understanding Epilepsy

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Understanding Defensive Driving Principles

Vehicle Dynamics and Handling

Defensive Observation and Safe Following Distance

Traffic Laws, Regulations and Vehicle Maintenance

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Defensive Driving in Adverse Weather and Nighttime

Managing Space and Visibility

Defensive Driving in Different Environments

Managing Driver Fatigue and Distractions

In this module, you’ll learn about vehicle dynamics and handling. We discuss the role of weight distribution, suspension, speed, and vehicle design in affecting stability. We also provide some basic and advanced braking techniques, such as gradual braking, threshold braking, engine braking, and more.

Handling Emergency Situations

Crash Avoidance Maneuvers

Post-Crash Procedures and First Aid

In this module, you’ll gain insights into emergency braking, types of braking systems, and adapting techniques to varied road conditions. You’ll learn about the types of skids and their effective control measures. We show you how to communicate effectively with emergency services and administer basic first aid and cardiopulmonary resuscitation.

Comprehensive Guide to Defensive Driving - Assessment

Equip yourself with the skills and techniques to avoid accidents and stay safe on the road with this free online course.

Comprehensive Guide to Defensive Driving

Driving is an essential aspect of our lives but carries various risks. Defensive driving is, therefore, essential for ensuring road safety while driving. This course aims to enhance your driving skills and minimize the chances of accidents by providing guidance on observing road conditions, anticipating dangers, maintaining vehicle control and more. Are you ready to become a safer driver? Enrol now and learn for free!

Introduction to Domestic Violence and Abuse

The Components of Domestic Violence

Domestic Violence on Victims

Domestic Violence and Abuse on Children

Risks of Domestic Violence and Abuses on Children

Supporting the Victim and Reporting Incidents

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Course Assessment

In this free online course, learn about identifying and reporting domestic violence and abuse in children and adults.

Fundamentals of Domestic Violence and Abuse

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