Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

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Hack-Proofing Medical Devices
Ensuring Product Safety through Cybersecurity

Medical devices are increasingly electronically connected — to patients, to providers, to networks, to each other. With these advances comes an increased risk of cybersecurity breaches that could affect a device’s performance and functionality and ultimately patient safety.

You need to stay on top of the potential for cyber attacks throughout your products’ lifecycle, beginning with design that discourages hacking and carrying through to postmarket protections that respond to ever-developing threats. 

Hack-Proofing Medical Devices will show you how to get — and keep — control of your devices’ networked operations. The management report covers:

  • Six environmental stressors that contribute to cybersecurity problems
  • The overwhelming magnitude of the problem — 68,000 medical devices were found to be freely accessible through the Internet in 2015
  • How the FDA and international regulators are handling issues involving software as a medical device (SaMD)
  • Types of cybersecurity threats, including ransomware and device piggybacking
  • How to determine the level of concern and exploitability for a particular device
  • How to conduct device hazard analysis
  • The FDA’s stance on cybersecurity as shown through recent guidances
  • The kind of data and documentation you need to keep to protect against liability claims
  • Key messages from the FDA delivered by CDRH’s Cybersecurity Program Manager

BONUS — the report also provides a variety of tools including:

  • A checklist for verifying a device’s cybersecurity controls status
  • A sample medical device cybersecurity policy
  • Spreadsheets that help assess level and severity of risk

Order your copy of Hack-Proofing Medical Devices and understand the nature of cybersecurity threats, how and where they occur and what you can do to prevent outside interference.

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PDF Edition


Available Format

PDF Edition — $397

Who Will Benefit

  • IT specialists
  • Design engineers
  • Computer coders
  • Quality control
  • Regulatory affairs
  • Legal affairs
  • Liability lawyers

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