Rajeev Yadav

Rajeev Yadav, Ph.D., is a biomedical engineer working at the intersection of regulated medical software development and medical-device conformity assessment.

He earned his Ph.D. in electrical and computer engineering from Concordia University in 2012, with a thesis on the automatic detection and classification of epileptic neural signals.

He has held senior research and development roles at Genia Photonics and at Reveal Surgical (formerly ODS Medical). At Reveal Surgical he was the first technical hire and served as Director and Senior Principal Scientist, responsible for system, software and algorithm design, development and testing, and for the quality system, cybersecurity and data governance supporting them. The work ran from early feasibility through multicentre clinical validation.

He subsequently served at a Notified Body as a Technical Specialist, Clinical Evaluation Specialist and Scheme Manager, assessing technical documentation and clinical evaluations for software and AI-enabled medical devices under the EU MDR.

He is a named inventor on two granted patents, publishes in peer-reviewed biomedical engineering journals, and serves as an Associate Editor of Circuits, Systems and Signal Processing. He is a certified lead auditor for ISO/IEC 42001 and ISO/IEC 27001. He co-founded itie Knowledge Solutions in 2004, which supports biomedical education in India.

He writes for the engineers, regulators and founders who have to build clinical systems that are trusted in use and cleared for market.