Courses / Bringing Software as a Medical Device to Market

Bringing Software as a Medical Device to Market

Hardian Health

Topic

11 hours

21 November 2024

Self Paced

About This Course

The market for medical devices is growing at around 5.5% per year, but what do you need to know, to be able to access that market? In this course, you can learn what medical devices are, how they are categorised, and how they are regulated. We will cover the strategies you can adopt in selecting which markets to bring your device to, the responsibilities and expectations on you to manage quality, and how your device will be evaluated, both from a clinical, and a health economics point of view.

Learning objectives

After completing this course, you will be able to:

Describe the different categories of medical device
Explain the differences between the three key markets for medical devices
List the risk classes and compliance processes used by regulators
Create a Quality Management System
Describe processes used to rectify quality problems
Explain how medical devices are evaluated for both clinical and health economics outcomes

Intended Audience

These videos are aimed at anyone interested in understanding the medical devices market better. This includes entrepreneurs interested in creating medical devices, clinicians who want to understand how the devices offered to them are regulated, and those interested in developing a career in this industry.