Interested in selling your medical device in the United States? If the answer is yes, the US Food and Drug Administration requires you to comply with its Quality System Regulation (QSR) outlined in 21 CFR Part 820. FDA QSR implementation can be a daunting task, especially for start-up medical device companies. In this free whitepaper, we provide a high-level overview of 21 CFR Part 820 and answer your biggest questions about the implementation process, including:
- Who needs to comply with FDA QSR 21 CFR Part 820?
- What are the key elements of the FDA QSR?
- What are the phases of the implementation process?
- How long does it take to implement the system?
- What factors affect the implementation timeline?
We'll answer all of these questions and more in this 7-page white paper.