contact@cdaqi.com Turnkey Services for Connected Medical Services
We offer a comprehensive suite of services to transform cybersecurity from a
reactive to proactive security first approach.
Electrical Safety & EMC Testing
Medical devices must meet strict global standards for electrical safety and electromagnetic compatibility (EMC) to ensure they are safe and do not interfere with other critical equipment.
Firmware & Hardware Security
Securing low-level device components through firmware extraction, reverse engineering, and secure boot validation.
SBOM & Vulnerability Management
Software Bill of Materials generation and post-market vulnerability management for long-term device security.
Cybersecurity Risk Assessment
We perform a comprehensive security assessment of your medical devices—including IoMT, IoT, and OT devices—to identify potential threats and vulnerabilities. This involves a deep dive into the device's architecture, communication protocols, and potential attack vectors.
Turnkey Testing & Calibration Services
Global Market Access CDAQi supports a diverse global customer base, comprising OEMs and Product Vendors with product testing, certifications and regulatory compliance services enabling seamless access to international market
Network & Protocol Security
Analysis of Bluetooth, Wi-Fi, LTE protocols, and API security testing to ensure safe communication.
Component & Module Cybersecurity
Assessment and compliance testing for embedded systems and wireless modules to secure each device component.
Audit, Compliance & Certification Support
Third-party attestation, detailed reports, and compliance mapping for FDA and MDR Annex I documentation.
AI Governance & Risk Management Framework
A comprehensive framework to manage the unique risks of AI/ML, including data integrity, bias, and explainability. This provides a structured approach to ensure ethical and safe AI operation.
Regulatory Readiness Audit AI enabled Medical Devices
We guide you through the complex global regulatory landscape for AI-enabled devices. Our experts help you prepare for flawless premarket submissions, including 510(k), De Novo, and PMA applications for the FDA, and technical files for the EU MDR and emerging AI Act.
Security Gap Analysis & Compliance Audit
We conduct a thorough analysis to compare your device's current security against major regulatory and industry standards, including FDA, ISO 14971, IEC 62304/81001, and UL 2900. This audit identifies any gaps in your security processes and documentation that need to be addressed.
Change Control & Lifecycle Management
A framework to manage changes to your AI/ML model or software, ensuring that all updates maintain compliance and are properly documented.
Looking for Something Else ?
Rigorous testing to ensure the device is ready for regulatory approval and market release.
Get a tailored readiness plan in 14 days - with prioritized fixes and regulatory mapping.
