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Medical Device Cybersecurity

Securing the future of healthcare

Medical device cybersecurity process.

Cybersecurity Consulting

We’re exerts in: 

  • Cybersecurity
  • Software
  • Medical Device Regulations

 

We can help by:

  • Supporting you in architecture design
  • Guiding selection of controls (encryption,  authentication, etc.)
  • Performing cybersecurity testing
  • Preparing the 12 cybersecurity attachments FDA requires

 

We’ll make sure your device safe and FDA-compliant. 

Our Services

System Architecture for Security

Collaborative design to secure your device from the ground up.

FDA Documentation and Compliance

We prepare the cybersecurity documentation FDA requires. 

Independent

Testing

FDA requires independent cybersecurity testing.

We perform fuzz and penetration testing for

  • web apps
  • mobile apps
  • cloud
  • embedded software

Who It’s For

Teams needing additional cybersecurity expertise.

Teams needing additional cybersecurity expertise.


Companies aiming to avoid FDA rejections due to cybersecurity gaps.

Companies aiming to avoid FDA rejections due to cybersecurity gaps.


Organizations needing an external security audit or independent testing.

Organizations needing an external security audit or independent testing.


Why Bold Type?

With ISO13485 certification, decades of cybersecurity experience, and a deep understanding of FDA standards, we provide expertise in both regulatory and technical cybersecurity, making us uniquely equipped to safeguard medical device software.

Contact us today to secure your software and protect patients.

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