Solutions

Our products are optimized for medical device manufacturers to build secure, innovative medical devices faster while meeting FDA cybersecurity requirements

SOLUTIONS

Products

SBOM & vulnerability management

Integrate and analyze your software supply chain to identify and mitigate vulnerabilities.

Data security & privacy

Encrypt data, manage devices, and streamline incident response.

End-to-end cybersecurity roadmap

Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.

REGULATORY BODiES

Regulatory bodies

FDA

Navigate cybersecurity compliance for your 510(k) submissions or pre-market approval (PMA) with ease.

EU MDR

How to navigate your EU Medical Device Regulation submissions.

Health Canada

How to navigate your Health Canada submissions.

Cryptography design and review

We identify gaps in your PKI and certificate management practices and create an actionable mitigation strategy.

Pricing

Services

Get the Medcrypt advantage with our expert team of FDA and medical device experts to prepare for FDA cybersecurity readiness via regulatory strategy, penetration testing, threat modeling, process optimization, and more.

SECURE DEVICE LIFECYCLE

All services

Regulatory strategy, penetration testing, threat modeling, and process optimization for FDA readiness.

Pre-market services

Accelerate FDA approval with expert guidance, including FDA cybersecurity readiness, threat modeling, PKI analysis, maturity assessments, and SDLC integration

FDA cybersecurity readiness
Threat modeling & risk mitigation
PKI & cryptography analysis
Cybersecurity maturity assessments
SDLC integration

Post-market services

Maintain patient safety and regulatory compliance
Including incident response, vulnerability management, risk management, SBOM validation, and compliance updates

Cybersecurity incident response
Vulnerability management & patch strategy development
Cybersecurity risk management
SBOM validation & monitoring
Regulatory change management & compliance updates

FDA SUBMISSION & RISK ASSESSMENT

FDA cybersecurity readiness

Get secure medical devices to market on schedule with peace of mind.

FDA cybersecurity filing remediation

Identify gaps and create prioritized plans to meet FDA requirements.

FDA hold letter response

Immediate guidance to navigate your response process.

Threat modeling

Protect your software ecosystem with continuous security improvements.

CASE STUDIES

100+ device security assessment

10-minute diagnostic transformed fragmented security into enterprise-wide visibility.

Secure connectivity business case

Risk analysis secured $1M+ investment by quantifying ROI.

Encryption architecture assessment

Encryption reviews and threat modeling for surgical robotics, avoiding costly delays.

Cardiac device PMA remediation

Remediated major deficiencies efficiently while controlling costs.

Vulnerability management

Automated SBOM analysis and reduced review time by 90%.

Cryptography design and review

We identify gaps in your PKI and certificate management practices and create an actionable mitigation strategy.

Learn

RESOURCES

Blog Case studies FDA compliance Whitepapers Webinars & conferences Webinars Events

DOCUMENTATION

Helm docs Guardian docs

Company

About us DEIB How we contribute Careers News Webinars Events

Back

Whitepaper

Understanding international medical device cybersecurity guidance

July 28, 2025

Medical device cybersecurity requirements from global regulators will continue to evolve as the industry and ecosystem matures. The industry must be cautious against over reliance on “security frameworks” and must rapidly iterate to keep up with emerging technology best practices.

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