Medical Device Solutions

Software Tools and Services Supporting FDA Regulations and Guidance

Services & Automation Software for Medical Device Cybersecurity

Assessments

Services to assess and implement FDA expected Secure Product Development Framework (SPDF)​

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Workshops

FDA focused Cybersecurity workshops for embedded software engineers, PMs, and managers

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FDA Submissions

Services to help you prepare cybersecurity information for FDA submissions

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Protection

Automation tools to add FDA recommend security, including OTA, in 2 weeks

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Testing

​Automation testing platform for FDA expected testing including robustness, fuzz, and penetration testing

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Detection

AI/Machine-learning based Intrusion Detection and Protection Software (IDPS) to detect cyber-attacks

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Why the FDA is Mandating Security

Several trends are impacting connected medical devices. Cybersecurity is critical as there are financial, data, and operational risks. More importantly, patient safety depends on it. 

Security Trends Impacting Healthcare Devices:

  • Significant growth in network-connected medical devices – 22% annual growth over the next 5 years.
  • Software complexity - more lines if code means more bugs. More bugs means more vulnerabilities.
  • Software supply chain is being exploited
  • Widely adopted technology, such as Ethernet & Linux, have known exploits
  • Skill gap – over 300K unfilled cybersecurity positions
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IoT Security Trends and Why the FDA is Mandating Security

In March 2023 the FDA issued : “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems"

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A medical device is classified as a “cyber device”, meaning that it needs security, if it:

  • Has software
  • Has a network interface (or a USB interface)
  • Could be adversely affected by a cyber-attack

​For pre-market submissions , medical devices manufacturers must:

  • Have a process that considers security from the start
  • Make sure devices are secure, including testing
  • Provide a software bill of materials
  • Submit a plan to monitor and address post market cybersecurity vulnerabilities.
  • Support a software update process for in field devices to address identified vulnerabilities. 

FDA Compliance Consulting Services

FDA Cybersecurity For Medical Devices

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Implementing Security for Medical Devices

BG Networks Cybersecurity Solution Map

BG Networks offers security automation tools that saves you significant time to meet FDA device cybersecurity requirements.  All 6 categories of device security, specified by the FDA, are covered with BG Networks automation solutions.

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