contact@cdaqi.com 
+1 4087346337 About Us - Safety and Compliance from
Concept to Market
Transforming connected medical devices with cutting-edge AI, Cybersecurity and Compliance solutions. We shift the focus from a "fix-it-later" model to a "secure-it-first" approach. By embedding security into the earliest phases of development, we mitigate risks and accelerate your time-to-market
Accelerating Safe and Compliant
Medical Innovation
To accelerate the development of safe and effective medical technologies by providing a comprehensive,
end-to-end approach to risk management and compliance. We combine deep industry expertise with cutting-edge
AI technology to protect patients, secure critical infrastructure, and ensure regulatory approval."
We Stand Apart With Proven Expertise
and Trusted Outcomes.
Our unique blend of technical expertise, data-driven insights, and deep regulatory knowledge streamlines your path to market
Regulatory Success
We help manufacturers secure FDA approval, ensuring pre-market and post-market cybersecurity requirements are met.
Accredited Excellence
Our Testing and Calibration Services are ISO/IEC accredited, adhering to stringent requirements for technical competence and quality.
Deep Technical Expertise
Our team’s deep understanding of MDR and FDA guidelines, AAMI TIR57, and global security standards ensures we address the unique challenges of the industry.
AI Advisory
We are committed to advancing fairness and building trust in AI-powered healthcare through services like audits, advisory and regulatory assessments.
The Challenges We Solve
Today’s healthcare equipment - including implantables, wearables, remote monitoring systems, and networked equipment - increasingly relies on IoT and cloud technologies. This reliance introduces significant vulnerabilities.
Cybersecurity Risks
Vulnerabilities in device software, network interfaces, wireless communication,cloud connectivity,expand the attack surface for wearables, implantables, and networked devices can be exploited for ransomware attacks, data breaches,data exfiltration, wireless/network exploits, cloud misconfigurations, or direct device control.
Regulatory Complexity
The ever-changing landscape of standards and regulations, including FDA Cybersecurity Guidance, EU MDR/IVDR, IEC 62443, and IEC 62304, requires continuous vigilance.
Partnerships
Our Trusted Partners
Turn AI Innovation into Secure, Compliant, and Trusted Medical Devices.
The CDAQi Advantage: Enabling Innovation
Our singular focus on the intersection of AI and Cybersecurity provides a significant return on
investment through a faster, more predictable path to market and a safer, more robust product.
Secure Your Innovation
We seamlessly integrate three critical areas: AI, Cybersecurity, and Regulatory Science. Our approach ensures that every step of your development process, from initial risk assessment to final submission, is aligned with global standards.
From Report to Roadmap
We believe that a report is only valuable if it provides a clear path forward. Our deliverables are not just documents; they are actionable roadmaps designed to accelerate your market entry and reduce costly rework.
Continuous Partnership
From premarket to post-market, we provide lifecycle management and turnkey services to keep your device secure and compliant as regulations evolve.
Here Is What Our Clients Are Saying About Us
Subramanian | Founder Ajnaa
CDAQi is an expert in CyberSecurity Testing Services and have great subject matter experts for any medical startup looking for Security Testing services. We found great benefit in working with them.
KS Madhavan | Founder & CEO CANCER HOPE
Risk management in medical devices goes beyond compliance - it ensures safety, reliability, and trust. Failures often stem from aging, misuse, or overlooked external factors, making robust, error-proof design essential. Beyond technical risks, human assumptions and knowledge gaps also play a role. Recognizing these, as highlighted in the Vedic concept of Maya, drives innovation and superior device outcomes.
Sivaprakash Anbalagan | Principal Partner - Embark Interactive
CDAQi is an expert in Cybersecurity Testing Services, with subject matter experts and a virtual CISO providing valuable guidance across ITSAR, EU compliance, enhanced VAPT, custom testing, audits, and regulatory requirements. Their structured three-phase cybersecurity testing approach has been highly effective in supporting both medical startups and large enterprises. We have found tremendous value in working with them.
Get a tailored readiness plan in 14 days - with prioritized fixes and regulatory mapping.
