contact@cdaqi.com 
+1 4087346337 Secure. Compliant. AI-Powered Healthcare.
Secure Your Innovation.
Accelerate Your Market Access.
Secure. Compliant. AI - Enabled Connected Healthcare.
Secure Your Innovation. Accelerate Your Market Access.
Our Core Services
We seamlessly integrate three essential pillars: AI Consulting, Cybersecurity-by-Design, and Regulatory Science. Every step of your development journey-from initial risk assessment to final regulatory submission-is synchronized with global standards, giving you a single trusted partner to guide you through today’s medical technology challenges.
Data Bias & Unfairness
AI models trained on skewed or unrepresentative datasets can lead to inaccurate or biased predictions, resulting in health inequities for specific patient populations.
01
Lack of Explainability
"Black box" AI models that lack transparent reasoning can undermine trust and hinder clinical adoption, as clinicians need to understand why a prediction was made.
02
Adversarial Attacks
Malicious manipulation of input data can cause an AI model to fail in critical situations, leading to incorrect diagnoses or treatment recommendations
03
Data Integrity & Security
The integrity of the data used to train and run AI models is paramount. Compromised data pipelines can corrupt a model's performance and lead to patient harm.
04
Regulatory Uncertainty
The fast pace of AI development often outpaces regulatory frameworks, creating a complex and ever-changing landscape for achieving and maintaining compliance.
05
Legacy Device Vulnerabilities
Older medical devices were not designed with modern security in mind and often run on outdated operating systems, creating significant entry points for attackers.
01
Lack of Secure Updates
The inability to securely patch and update devices leaves them vulnerable to new threats and exploits long after they are deployed in a clinical setting.
02
Third-Party Component Risks
Devices are built with components from a variety of vendors, and a single vulnerability in a third-party piece of software or hardware can compromise the entire product.
03
Increasing Connectivity
The growth of IoMT (Internet of Medical Things) creates more network attack surfaces, requiring robust security measures to protect every single connected device.
04
Insider Threats
Whether through accidental human error or malicious intent, threats from within an organization can lead to data breaches and device tampering.
05
The Evolving Challenge: A Unified Approach to Risk Management
Our philosophy of "Unified Risk Management" ensures that security for both the device and its AI model is a core pillar from the very beginning. This holistic approach prevents costly redesigns and enables a faster, more compliant path to market.
The Traditional Reactive Approach
- 1. Develop Device & AI Model
- 2. Test for Security at the End
- 3. Discover Critical Flaws
- 4. Costly Redesigns & Market Delays
Our Proactive Integrated Approach
- 1. Plan Security, AI Validation & Develop
- 2. Continuous Testing & Monitoring
- 3. Validate Controls & Model Integrity
- 4. Accelerated, Compliant Market Entry
Scorecards
Cybersecurity Readiness reflects resilience against common threats, known vulnerabilities, and attack vectors.
Regulatory Readiness indicates alignment with FDA guidance and EU MDR requirements.
Get a tailored readiness plan in 14 days - with prioritized fixes and regulatory mapping. Request Readiness Assessment
Key MedTech AI Risk Metrics & Actions
| Risk Category | Score | Actionable Insight |
|---|---|---|
| Data Bias & Fairness |
75% | Re‑evaluate training data for diversity; expand representativeness & labeling QA. |
| Adversarial Attack Resilience |
55% | Prioritize adversarial training, input sanitization, and runtime anomaly detection. |
| Model Explainability |
90% | Maintain explainability artifacts for regulatory review; integrate into clinical risk files. |
| Data Integrity & Privacy |
95% | Excellent pipeline controls; continue privacy‑by‑design & encryption‑in‑depth. |
| Performance Robustness |
70% | Expand edge‑case testing; add noise/perturbation suites and stress testing. |
All testing conducted to quality principles; mapped to ISO 14971 risk management and IEC 62304 lifecycle controls.
Why Our Structured Approach Matters
This tailored approach directly supports our core differentiator-the integrated, end-to-end solution by focusing on All-in-One AI/ML and Cybersecurity Solution, from Report to Roadmap and continuous partnership Premarket to Post-Market.
Partnerships
Our Trusted Partners
Our Success Stories
Our success stories highlight how we help organizations ensure compliance with confidence, build safety and security, and accelerate go‑to‑market readiness by eliminating rework and streamlining evidence preparation.
Client : A digital startup in India preparing a premarket FDA 510(k) submission for AI-Enabled Medical device.
Challenge : Needed cybersecurity testing and documentation for regulatory readiness and compliance.
Our approach : Delivered a structured Three-Phase Regulatory Roadmap covering technical and documentation standards, co-developing regulatory strategies, compliance plans, and reviewing validation and testing reports.
Impact : Streamlined submission process by early identification and mitigation of cybersecurity vulnerabilities, ensuring patient safety and regulatory compliance for global market.
Client : Health Innovators, preparing their first wireless, cloud-connected medical device for FDA premarket submission.
Challenge : The team needed to meet new FDA cybersecurity requirements, including thorough threat modeling, vulnerability reporting, and providing a complete Software Bill of Materials (SBOM) as part of their 510(k) application.
Our approach : We collaborated on a tailored phase wise cybersecurity testing plan—prioritizing network and Bluetooth security, guided the documentation process for compliance, and helped develop diagrams and mitigation strategies required for the submission.
Impact : This approach enabled the client to identify and address two interface vulnerabilities before FDA review. Their complete, clear cybersecurity documentation led to no “Additional Information” (AI) requests from the FDA, allowing for a smoother, quicker premarket review and first-attempt clearance.
Client : A medical device manufacturer faced rising post-market security threats to their deployed product base.
Challenge : Their installed devices were exposed to emerging vulnerabilities.
Our approach : We implemented a robust continuous monitoring framework and performed in-depth vulnerability assessments, enabling rapid identification of critical weaknesses. Our team delivered a fast-track mitigation plan and provided proactive advisory on patch deployment and customer communication.
Impact : Within weeks of implementing continuous monitoring, the client detected a critical vulnerability affecting remote access protocols in a segment of their installed devices. Through coordinated rapid-response efforts, they quickly issued software patches and notified all affected customers.This prompt action prevented potential device downtime, and avoided disruption of patient care, demonstrating tangible risk reduction and effective stakeholder communication.
Our Cornerstone Services
Our service is a unique blend of AI + Cybersecurity + Regulatory Science, in depth domain expertise,
providing a holistic view of your device's security posture.
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.
