Are you ready to sell your medical device in the United States? If so, your company must comply with the US FDA Quality System Regulation (QSR), specifically known as 21 CFR Part 820. Even if you already have a quality management system in place, such as ISO 13485, your quality system must meet this regulation before you can sell your device. In this video, we’ll take a look at 21 CFR Part 820 and what the regulation entails. We’ll discuss:
- An overview of 21 CFR Part 820
- Key players in the QSR implementation process
- Examine important sections of QSR
- What it takes to maintain compliance
You’ll learn all this and more in this short video.