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:
You’ll learn all this and more in this short video.
Hosted by the University of Illinois, this special webinar was developed to explain what non-medical manufacturers need to know to help alleviate s
read moreIt has been one year since the FDA released the latest Guidance Document pertaining to managing Cybersecurity in Medical Devices. What impact is th
read more