AAMI eXchange 2024

Solutions

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

FDA SUBMISSIONS

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.

Device monitoring & incident response

Monitor device behavior and receive incident alerts.

FDA SUBMISSIONS

Regulatory bodies

FDA

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

EU MDR (coming soon)

How to navigate your EU Medical Device Regulation submissions.

Health Canada (coming soon)

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.

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.

FDA SUBMISSIONS