Medical Device Cybersecurity

As technology becomes increasingly mobile and devices become more connected than ever before—be it via wireless, the internet, or the cloud—the risk of network breaches is on the rise, which could have life-threatening consequences. While the FDA cybersecurity guidelines serve as an invaluable guide that helps manufacturers reduce the cybersecurity-related threats of patient illness, injury, or death, there is no one-size-fits-all approach that will ward off all potential threats. By its very nature, each medical device cybersecurity risk may take on its own unique form from a single disruption.

Medicine doctor pushing on first aid sign with modern computer interface

At Sterling, our team uses agile project management methods to eliminate extraneous elements that could threaten the medical device’s cybersecurity, create vulnerabilities, or present other potential risks associated with each individual medical device—all while moving the devices forward in the approval process.

We are experts in the constantly evolving FDA cybersecurity guidelines, European Union standards, and dozens of other government regulations, and we have vast experience in 510(k) and Pre-Market Approval processes for all classifications of medical devices. We know what it takes to design the most compliant, safest medical devices aimed at improving the health of patients.

In accordance with FDA regulations, we’ll help you:

  • Assess the impact on the device’s functionality, the impact to the patients, the likelihood of the threat, and the device’s vulnerability to a breach
  • Determine the risk levels and understand different mitigation strategies for medical device cybersecurity risks
  • Establish a medical device cybersecurity management approach that identifies assets and threats and examines corner cases.

Want to learn more about how to protect your device from cyber threats? Contact our team today.

Resources

January 27, 2015

Guidelines to Follow When Creating Mobile Medical Device Apps

Many new software applications are being developed for use on mobile platforms (smart phones, tablets, etc.). Before delving into the steps to be taken to develop such an application, we should first...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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