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Optimizing your path to FDA cybersecurity readiness

Get your secure medical devices to market on or even ahead of schedule, with peace of mind.

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Actionable roadmaps

Medical device cybersecurity is a hard problem to solve. Our Services team provides actionable roadmaps to facilitate product development, quality, and security frameworks to meet your pre- and post-market needs. No matter where you are in your process, we enhance your processes and agile methodologies to get to market, while optimizing your resources.

Need cybersecurity strategy help

FDA cybersecurity readiness

Optimize your path to FDA cybersecurity readiness. We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you. Get your secure medical devices to market on or even ahead of schedule, with peace of mind.

FDA hold letter response

Get immediate guidance to navigate your response process effectively.

Threat modeling

Ensure your software ecosystem is protected and incorporate continuous security improvements into your design and engineering processes. We do a deep-dive investigation into your architecture, design, requirements, and implementation to create threat models that review current state, refine trust boundaries, identify requirements, and propose remediations, ensuring that your hardware, firmware, software, network communication, and data handling components to ensure you are protected now and in the future.

Cryptography design and review

We assess your PKI and certificate management practices, perform gap analysis with industry best practices and regulatory guidance, and develop realistic and actionable mitigation strategies for medical devices.

Maneuver FDA steps with peace
of mind

We understand how quickly the security landscape is changing, and how important it is to your business and patients to ensure the maximum probability of regulatory approval. Our team of FDA analysts, medical device experts, and cybersecurity engineers are here to help.

FDA Cybersecurity Filing Readiness Survey

The expertise of MedCrypt's specialists can pinpoint gaps and develop a targeted plan to address issues, guaranteeing that the submission meets all requirements for acceptance.

FDA Cybersecurity Filing Remediation

For MDMs who do not pass the FDA Filing Readiness Survey or face an FDA refusal, MedCrypt's experts can help identify gaps and create a prioritized plan to rectify issues, ensuring the submission becomes acceptable.

Threat Modeling

Our expert threat modeling identifies and reduces security issues that impact your FDA readiness and getting your device to market on time.

FDA Cybersecurity Hold Letter Response

In the event of an FDA hold letter, MedCrypt provides immediate guidance to navigate the response process effectively.

FDA Cybersecurity Submission Readiness

Designed for MDMs with submissions either already under FDA review or planned for the near future, this service offers a comprehensive review using MedCrypt's unique five-sector framework (review of threat modeling, post-market management, vulnerability management, security risk assessment, and SBOM processes and outcomes) to ensure cybersecurity compliance

Maneuver FDA steps with peace
of mind

We understand how quickly the security landscape is changing, and how important it is to your business and patients to ensure the maximum probability of regulatory approval. Our team of FDA analysts, medical device experts, and cybersecurity engineers are here to help.

FDA Cybersecurity Filing Readiness Survey

A free assessment for MDMs to gauge submission readiness by responding to survey questions aligned with the new FDA guidance, including RTA (Refuse to Accept). This service provides valuable insights into the risks to acceptance for the submission.

SBOM & vulnerability management
FDA Cybersecurity Filing Remediation

For MDMs who do not pass the FDA Filing Readiness Survey or face an FDA refusal, MedCrypt's experts can help identify gaps and create a prioritized plan to rectify issues, ensuring the submission becomes acceptable.

SBOM & vulnerability management
FDA Cybersecurity Submission Readiness

Designed for MDMs with submissions either already under FDA review or planned for the near future, this service offers a comprehensive review using MedCrypt's unique five-sector framework (review of threat modeling, post-market management, vulnerability management, security risk assessment, and SBOM processes and outcomes) to ensure cybersecurity compliance

SBOM & vulnerability management
Threat Modeling

Our expert threat modeling identifies and reduces security issues that impact your FDA readiness and getting your device to market on time.

SBOM & vulnerability management
FDA Cybersecurity Hold Letter Response

In the event of an FDA hold letter, MedCrypt provides immediate guidance to navigate the response process effectively.

SBOM & vulnerability management

Take the FDA readiness survey

Take a free assessment to gauge your submission readiness with questions aligned with the latest FDA expectations.

FDA FAQs

How long do I have to fix any FDA issues?
What does Refuse to Accept mean?
I have already passed FDA requirements with my current strategy, why should I switch?
How can I determine whether my device is a cyber device?
What if I already submitted my cyber device?
ON-DEMAND WEBINAR

FDA ‘Cybersecurity Refuse to Accept Policy’ (RTA)

Medcrypt’s own FDA expert, Naomi Schwartz, discusses what the new policy means for medical device manufacturers (MDMs) like you.

Watch the webinar
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Are you FDA-ready?

Get your secure medical devices to market on or even
ahead of schedule, with peace of mind.