boldtype

Get an Instant Quote

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

"Bold Type has been a trusted product development partner since our earliest days. They not only led the development of the Leva® Pelvic Health System, including fundamental engineering, prototyping and software design, they have also worked seamlessly with our internal team to continuously improve our app for greater patient engagement and satisfaction."
Jim O'ConnorCFO, Axena Health
"For sophisticated systems that include embedded software, mobile applications, and cloud, Bold Type's expertise in cybersecurity is truly unparalleled in the industry. They've been a trusted partner for years and I couldn't recommend them more highly."
Michael FongFounder/CEO Privoro
Previous
Next

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

Get an Instant Quote