DRX Cyber
Regulatory Strategy
Since 2013, FDA’s Center for Device’s and Radiological Health (CDRH) has paid increasing attention to the cybersecurity of medical devices. As CDRH continues to increase their scrutiny, companies will need a comprehensive strategy to meet current and future regulatory needs.
Premarket
FDA released their final premarket guidance in 2014 and a draft update in 2018. Meeting the expectations of these guidance documents will be critical to reaching the market on time. Whether you’re in the R+D planning stages, gearing up for a submission, or dealing with deficiencies, DRX will guide you to through.
Postmarket
The FDA released their final postmarket guidance in 2016, which details the Agencies’ expectations for managing cybersecurity risk for marketed devices. Medical Device Manufacturers (MDMs) are now under increasing pressure to manage all cybersecurity risk and vulnerabilities in their fielded products. DRX will guide you.