Rajeev Yadav
Co-founder @Itie Knowledge Solutions, Bangalore
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WORK HISTORY
Co-founder @Itie Knowledge Solutions, Bangalore
Bangalore, IN
Co-founded an India-based biomedical product development, R&D consultancy, and technology education company started by IIT alumni — focused on embedded biomedical systems, DSP, and applied ML- Provide periodic advisory on Brain-Computer Interface (BCI) and biomedical R&D projects to industry and academic clients (non-paying, non-overlapping with other engagements)- Active product portfolio includes portable EEG systems, BCI / virtual reality interfaces, multi-channel biosignal data acquisition (iMediLogger), neurostimulation, and portable digital X-ray- Academy arm trains engineers in MATLAB, DSP, and biomedical signal processing for industry and university partners across India and internationally.
EDUCATION
Concordia University
Doctor of Philosophy (Ph.D.), Electrical Engineering, Signal Processing, Pattern Recognition, Biomedical Engineering
Indian Institute of Technology, Delhi
Graduate Studies in Biomedical Engineering, Bioengineering and Biomedical Engineering, Machine Learning, Medical Devices
Deendayal Upadhyay Gorakhpur University
Bachelor of Science (BSc), electronics
Deendayal Upadhyay Gorakhpur University
Master of Science (MSc), Electronics
SKILLS
ABOUT RAJEEV YADAV
Most AI medical device teams don\'t fail because the model doesn\'t work. They fail because the submission falls apart.I\'ve spent my career building AI/ML medical devices, and the last two years assessing them at a Notified Body. I now help AI-SaMD startups close the gap between those two worlds.The path is unusual on purpose. Biomedical signal processing (PhD). Vital-signs ML at Ottawa Hospital Research Institute. Hyperspectral imaging at Genia Photonics. Laser-based cerebral bleed detection at Leap Medical. Founding-team R&D at Reveal Surgical, building the Sentry™ surgical AI platform from first principles. Technical assessor at a Notified Body, reviewing Class IIa/IIb AI/SaMD and active devices under EU MDR.Most engineers in this space spend a career inside one device class, one modality, one regulatory pathway. I\'ve shipped or assessed across most of them — and the pattern recognition that builds is hard to acquire any other way.At Reveal Surgical (formerly ODS Medical), I was the first technical hire after the CEO and led the build of the Sentry™ System — a real-time AI intraoperative cancer detection platform pairing Raman spectroscopy with machine learning. Hybrid C#/MATLAB/Python stack, ML pipelines, V&V, and submission-grade documentation for FDA, Health Canada, and EU MDR. Led an R&D team of 8 at peak. Lead inventor on the granted patents (US12••••88B2, JP72•••09B2). Co-author on the multicenter Sentry validation study in Scientific Reports (2024):>90% sensitivity and specificity across glioblastoma, brain metastases, and meningioma.Then I joined a Notified Body as Technical Specialist and Scheme Manager — Class IIa/IIb AI/ML and software certifications under EU MDR. Initial conformity, surveillance, vigilance, change notifications, certificate lifecycle, both technical and clinical.That seat changed how I architect systems. It\'s one thing to build for compliance; it\'s another to know exactly what an assessor flags, and why.Today I advise AI-SaMD founders and exec teams on regulatory strategy, AI/ML validation, and submission readiness across FDA, EU MDR, and Health Canada — helping teams avoid the rework cycles that kill 12–18 months of runway.Open to senior leadership in clinical AI, SaMD, and surgical intelligence — Director/VP/Head of AI, founding engineer/CTO at MedTech ventures. Fractional advisory ongoing. Canada, US, or remote.If you\'re building AI that has to actually reach patients — let\'s talk.#SaMD #MedTech #HealthcareAI #EUMDR #FDA #MedicalDevice #AIinHealthcare #DigitalHealth #RegulatoryAffairs #NotifiedBody
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