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Keeping network-connected medical devices cyber-safe is necessary to protect patients, patient data, and reduce regulatory risks. Failure to meet regulator expectations for cybersecurity could also delay your device clearance. Our team helps medical device manufacturers and developers meet FDA guidance for device cybersecurity.
Our cybersecurity assessments are based on NIST Cybersecurity Framework (CSF) and considers FDA pre- and post-market requirements. The goal of each assessment is to determine if gaps exist between your overall organizational processes and current best practice and regulatory guidance documents. As part of our assessment, we will support your team’s efforts toward these key objectives:
As experts in medical device cybersecurity, Emergo is dedicated to helping you meet regulatory requirements and bring safe, secure devices to market. We have helped companies around the world become FDA compliant. Here’s how we can help you:
Please contact us for more information about FDA cybersecurity assessments for network-connected medical devices.