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What actually counts as a medical device? Are there different types of medical devices? How do I begin to know what my regulatory path will be? Get the answers to these questions and more in this course!

Learn more about risk management for medical devices. 

What are Design Controls? What do the various regulations require in regards to Design Controls? These answers and more are available in this course.

Learn what the regulations say about training management and how to best implement it into your QMS in this overview course.

Learn the difference between audits, inspections, and the different types of each that you may encounter in the medical device industry.

With software being a growing industry, in general, it is no surprise that this popularity is making its way to medical devices. This course will give a quick overview of what we mean as Software as a Medical Device, as well as what the regulations say about it. 

Anyone looking to launch a medical device in the United States market should be familiar with the FDA and the regulations they use. This course will give you a look at the regulations themselves and a little history on the FDA and how it came to be. 

Get to know this common FDA clearance path and understand when you'll need to use it.

There have been many changes to the process of bringing a medical device to market in the EU. This course will highlight a bit of history as well as best practices for the current state of the EU MDR. 

So you have an idea for a medical device...what now? This course gives a quick overview of the process of developing a medical device and offers a few practical examples from our experiences in the industry. 

This course will describe the role of risk management in the industry, explain the framework of the risk process, and define many key terms that you'll need to know.