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Medical Device Cybersecurity Consulting

Ensuring FDA-compliant cybersecurity for every device.

Cybersecurity Consulting

Bold Type’s cybersecurity consulting services ensure that your medical device software meets the highest standards for security and compliance.

We have the technical and regulatory expertise to minimize security and compliance risks.

From penetration testing to preparing your FDA documentation, we cover all aspects of cybersecurity to keep your device safe and FDA-compliant. 

Our Services

System Architecture for Security

Collaborative design sessions to help you build secure software from the ground up.

FDA Documentation and Compliance

We can prepare all of the cybersecurity documentation for FDA submissions, reducing your team’s burden and regulatory risk.

Independent

Testing

FDA requires your cybersecurity testing to be performed by an independent party. We can perform rigorous cybersecurity test

Who It’s For

Startups with in-house teams needing additional cybersecurity expertise.

Startups with in-house 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 ISO 13485 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.

Success
Success

Client Success

“Our device was cleared before the FDA updated its cybersecurity guidance in 2023. When we submitted an application to expand our indications, FDA came back with a host of cybersecurity questions. The Bold Type team’s experience was critical to helping us address FDA’s feedback and quickly prepare the documentation supporting clearance. When it comes to medical device cybersecurity, these guys are legitimate experts.”

Jim O'Connor

CFO, Axena Health

Contact us today to secure your software and protect your patients.

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