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Penetration Testing

Cyber security and network protection with cybersecurity expert working on secure access internet to protect server against cybercrime. Person typing on computer keyboard late at night

With all its positives, the ever-evolving and ever-advancing nature of technology has also created challenges, which are even more pronounced in the healthcare industry where a person’s health, safety, and private information are involved. As continuous as the advancements are, equally as persistent are the malicious attempts to compromise these systems and take advantage of any weakness. As technology accelerates, so do cyber-attacks, endangering the safety and privacy of everyone involved in producing and using the device.

It is the responsibility of the manufacturer to safeguard its medical devices and ensure they are hardened against cybersecurity threats. Vulnerability testing is a key component to a robust cybersecurity strategy, but it is no longer enough.

As you are looking for the most cutting-edge way to help your customers and patients, hackers are trained to look for creative ways to breach it. That’s where penetration testing comes in.

Penetration testing includes additional evaluation to ensure that every medical device cybersecurity weakness has been identified and battle tested. Our team of independent, credentialed experts will:

  • Evaluate your system to determine all possible points of attack
  • Craft a structured plan to attempt to subvert all implemented security controls, or lack thereof
  • Track down any remaining vulnerabilities in your system and attempt to exploit them using modern, sophisticated methodologies
  • Provide you with detailed results on what they identified including recommendations to address any remaining weak points

Penetration testing not only ensures your device is safe from cyber threats, but it also helps you comply with the FDA’s and other regulatory bodies’ cybersecurity regulations. Along with your submission, those regulatory bodies want to see a report showing that penetration testing was completed by independent, certified testers following a structured plan including the testing outcomes.

Medical device cybersecurity is particularly complex, but an absolute necessity to maintain the safety and wellbeing of all involved parties. Have you ensured your device is protected from every possible vulnerability?

You don’t have to do it alone. Sterling Medical Devices can help. Contact us today to learn more about our medical device penetration testing services.

Resources

FDA 510(k)-Clearance-Approval

January 10, 2022

The COVID-19 Pandemic and 510(k) Clearances

The global COVID-19 pandemic, and the subsequent public health emergency it created, changed much about our everyday lives, and the medical device industry is no exception. To respond quickly to...
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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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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