You want to get your product to market as quickly as possible, but to do so, you need to ensure you are complying with the strict regulations mandated across the medical device industry. Failing to do so can put your business—and more importantly, your end-users—at risk. Navigating the murky waters of U.S. Food and Drug Administration (FDA) regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers.
Sterling can help.
Before bringing a medical device to market in the United States, it is essential to determine the proper classification and applicable regulatory requirements it must adhere to in order to ensure patient and user safety. With Sterling’s regulatory strategy support, we help you identify and address key FDA requirements for your device including:
- Product code and regulation number determination
- Classification determination
- Identification of applicable standards and guidance documents
- Confirmation or identification of potential predicate devices
- List of applicable tests
- Premarket pathway strategy
- Quality system requirements