All pricing is per organization.Enroll your company as a MedISAO member today and satisfy a key component of the FDA's guidance on Postmarket Cybersecurity.
Helm is Medcrypt's continuous Software Bill of Materials (SBOM) and vulnerability solution built specifically for medical device manufacturers (MDMs), providing full visibility across your entire medical device software supply chain to detect, prioritize, and remediate cybersecurity risk.
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.
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.
What are the benefits of joining MedISAO?
Satisfy a key component of FDA's Guidance on Postmarket Cybersecurity
Take advantage of the included Coordinated Vulnerability Disclosure Program
Get Customized vulnerability alerts from our vulnerability database
Avoid costly correction reporting via 21 CFR 806 when vulnerabilities are found
Access high-quality training materials and security tools
Learn and share best practices in a rapidly evolving field
Reduce patient harm and increase privacy and security for everyone
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