FDA Cybersecurity Guidance Consulting

ANSWERED ON THIS PAGE:

• How can we improve our connected medical device’s cybersecurity posture, meet FDA guidance, and simplify global market access?
• Can we leverage international consensus standards to improve our device’s speed to market?
• Will complying with cybersecurity guidance documents enhance our FDA submission timelines?

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.

Cybersecurity assessments to ensure FDA compliance

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:

• Identifying cybersecurity risks to network-connectable products, systems, and risks to patient privacy.
• Developing safeguards for the delivery of essential services and limit the impact of cyberattacks.
• Understanding and developing actions to take in the event of a cyberattack.

Emergo can assist with FDA cybersecurity compliance for your medical devices

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:

• Adhere to FDA recognized standards - Ensuring your device submission meets FDA guidance and/or demonstrates compliance with recognized standards like UL 2900.
• Improve device cybersecurity – Evaluate your network-connected medical devices for cyber risks or vulnerabilities and identify solutions.

Please contact us for more information about FDA cybersecurity assessments for network-connected medical devices.