MedCrypt

Targeted remediation service for manufacturers who do not pass the FDA Filing Readiness Survey or face an FDA refusal.

Medcrypt Helm automates SBOM and vulnerability management for medical devices with intelligent risk prioritization, CI/CD integration capabilities, bulk remediation workflows, and compliance reporting features designed for medical device manufacturers navigating FDA requirements.

A cybersecurity intelligence platform that helps medical device manufacturers benchmark their security posture, quantify the financial risk of vulnerabilities, and prioritize cost-effective mitigation paths to accelerate regulatory approvals.

Comprehensive cybersecurity regulatory compliance services for medical devices covering both premarket services and postmarket services led by former FDA policy experts.

A threat modeling service and software capability that drafts scenarios and attack trees from your device architecture, aligning with recognized methodologies like STRIDE and generating submission-ready outputs for FDA compliance.

A medical device cryptography platform featuring automated key management, secure storage, and built-in PKI designed to secure device-to-cloud and local network communication.

Comprehensive consulting and advisory services to navigate cybersecurity compliance for 510(k) submissions and pre-market approval (PMA), ensuring medical devices meet FDA cybersecurity guidance.

Assessment of PKI and certificate management practices, performance gap analysis, and development of mitigation strategies.

Comprehensive encryption architecture reviews combining technical analysis with regulatory expertise from former FDA reviewers, including structured threat modeling workshops, tailored standard operating procedures (SOPs), and a prioritized remediation plan.

Embedded cybersecurity expertise and targeted remediation services to help medical device manufacturers address PMA cybersecurity deficiencies and gain FDA approval.

A template and model implementation of a Secure Product Development Framework (SPDF) enabling medical device manufacturers to demonstrate compliance with security regulations.

Comprehensive consulting services and actionable roadmaps to navigate cybersecurity compliance for EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) submissions.

Partner to develop and implement postmarket management plans and activities.

Essential security bundle tailored for startups or budget-conscious MDMs prioritizing simplicity and affordability.

Enhanced support bundle for MDMs encountering growth obstacles and navigating regulatory challenges.

Premium support bundle for MDMs prioritizing innovation, collaboration, and regulatory excellence.

Services providing actionable roadmaps to facilitate product development, quality, and security frameworks for medical devices.

A cybersecurity advisory and readiness service designed to help medical device manufacturers transition from theoretical readiness to decisive action during security incidents, meeting pre- and post-market regulatory requirements.

An enterprise-wide maturity assessment and heat map service designed to evaluate medical device security posture consistently across diverse device types and development stages.

Immediate guidance and navigation support for responding effectively to FDA hold letters.

A risk analysis model and consulting service that quantifies a medical device manufacturer's current risk exposure across regulatory, reputational, and financial dimensions to secure executive buy-in and investment.

Access the Medical Device Information Sharing Analysis Organization community and resources.

RTI Connext is a standards-based, proven software connectivity framework for securing communication interfaces, independent of network location or transport, providing zero-trust security for data in motion.