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.

Stakeholders and Service Delivery

Continuous Improvement and Managing Quality

Quality and Team Building

In this module, you will learn how to identify the different stakeholders and manage their expectations before measuring the quality of health services. We cover the various stages of continuous improvement, the responsibilities of improvement facilitators and how to control quality.

Managing Quality and Service Delivery in Healthcare - Course Assessment

Learn how to manage the quality of service delivery to improve overall patient satisfaction in this free online course.

Managing Quality and Service Delivery in Healthcare

According to the WHO, one in 10 hospital patients in high-income countries suffer some sort of injury while receiving treatment. Low- and middle-income countries have 5.7 to 8.4 million deaths annually related to poor-quality care. This course will teach you how to manage quality care and offer safe, effective, and timely healthcare service. You will also study the theories of quality and explore team-building techniques.

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