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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.

Questions? Request more information from our specialists

CONTACT US >

REGISTER NOW: To Err is Human: A Documentary Film Screening and Discussion on Preventing Human Errors in Medical Technology, Dec 6, 2018 to Dec 6, 2018 in ,

FIND OUT MORE >

Anura S. Fernando

Principal Engineer for Medical Software & Systems

Justin Heyl

Cybersecurity Director

United Kingdom

150, Cambridge Science Park
Milton Road
Cambridge CB4 0GN
+44 (0)1223 214 044

USA

205 W Wacker Drive
Floor 13, Suite 1300
Chicago Illinois 60606
847 664 1363

USA

300 Baker Avenue
Suite 200
Concord Massachusetts 01742
978 371 2700

Netherlands

Arthur van Schendelstraat 600-G
MJ Utrecht,
The Netherlands 3511
+31 263 764 985

Japan

Marunouchi Trust Tower Main Building 6F
1-8-3 Marunouchi, Chiyoda-ku,
Tokyo 100-0005
+81 3 5293 6041