All regulatory process charts are available to download from Regulatory Affairs Management Suite (RAMS).
Log into RAMS or create your free account to download this information.


Get unlimited access to the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

In Depth: US FDA Medical Device Registration and Compliance
Information current as of January 2017. The US market represents more than 40% of the global market for medical devices. Yet for many manufacturers,
Read More
Overview of the USA FDA Classification Process
Classification is arguably one of the most important steps in the US FDA medical device approval process. Understanding how the US FDA classifies
Read More
In Depth: 21 CFR Part 820 - FDA Quality System Regulation
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),
Read More
How to Prepare for an FDA Inspection
Are you ready for a random audit by the FDA? If you are lucky, you might only have a few weeks or even days to get ready for a visit from the FDA.
Read More