Why should you partner with a United States contract manufacturer to develop and build your cardiovascular medical device? In this talk, we'll show you how partnering with a US based manufacturer can ease the experience of working with the FDA.
A US contract manufacturer can help you navigate the particular design control and good manufacturing practice requirements of the FDA. This is particularly valuable for addressing software design controls and the FDA's focus on human factors engineering. A contract manufacturer with regulatory expertise can also offer guidance on regulatory paths, FDA clinical trial expectations, and FDA material management requirements.
A strong partner near your largest potential market can help bring to device to market on-time and with budget.
