Turnkey Services

Turnkey Services for Connected Medical Services

We offer a comprehensive suite of services to transform cybersecurity from a 
reactive to proactive security first approach.

Medical AI
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.

Medical AI
Firmware & Hardware Security

Securing low-level device components through firmware extraction, reverse engineering, and secure boot validation.

Medical AI
SBOM & Vulnerability Management

Software Bill of Materials generation and post-market vulnerability management for long-term device security.

Medical AI
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.

Medical AI
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

Medical AI
Network & Protocol Security

Analysis of Bluetooth, Wi-Fi, LTE protocols, and API security testing to ensure safe communication.

Medical AI
Component & Module Cybersecurity

Assessment and compliance testing for embedded systems and wireless modules to secure each device component.

Medical AI
Audit, Compliance & Certification Support

Third-party attestation, detailed reports, and compliance mapping for FDA and MDR Annex I documentation.

Medical AI
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.

Medical AI
Regulatory Readiness Audit AI enabled Medical Devices

A final, comprehensive report summarizing your readiness for a regulatory submission, highlighting all completed tasks and providing a clear path forward.

Medical AI
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.

Medical AI
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.

AI Strategy & Consulting
AI Strategy & Consulting

AI Strategy & Governance is the structured approach organizations use to align artificial intelligence initiatives with business objectives, ethical principles, and regulatory requirements. It combines visionary planning and rigorous oversight to maximize AI’s value while minimizing risks.

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CyberSecurity Services
CyberSecurity Services

Our strategy is a continuous, two-phase journey that integrates security from initial design through the device's entire lifecycle, ensuring safety, compliance, and patient trust.

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Regulatory Support
Regulatory Support

Regulatory Strategy & Governance is the structured approach organizations use to anticipate, interpret, and comply with evolving laws and regulations. It aligns compliance initiatives with business objectives, minimizing risk while enabling growth. Strong governance frameworks ensure accountability, transparency, and ethical decision-making.

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Ready to move from score to submission?

Get a tailored readiness plan in 14 days - with prioritized fixes and regulatory mapping.

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