Aditya Joshi
Principal Digital Health Architect @Nuralogix Corporation
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WORK HISTORY
Principal Digital Health Architect @Nuralogix Corporation
EDUCATION
University of Illinois Chicago
Master's degree, Healthcare Informatics (Information Technology)
Mumbai University Mumbai
Bachelor's degree, Biomedical/Medical Engineering
ABOUT ADITYA JOSHI
Digital health technology leader with 11+ years of experience designing and governing regulated software development environments for Software as a Medical Device (SaMD) platforms.My work focuses on architecting compliant Software Development Lifecycles (SDLC) for digital health systems and helping organizations successfully deliver medical device software aligned with global regulatory frameworks including ISO 13485, IEC 62304, ISO 14971, FDA guidance, CE marking, and MDSAP.Throughout my career, I have helped organizations transition from ad-hoc engineering practices to structured, audit-ready development environments. By establishing governance across design controls, risk management, verification and validation, and release management, I have enabled teams to deliver compliant digital health products and successfully support regulatory approvals.Currently, I lead digital health engineering initiatives focused on:• Architecting regulated SDLC frameworks for Software as a Medical Device (SaMD) platforms• Driving engineering transformation and compliance readiness across global teams• Enabling traceability across requirements, development, verification, validation, and regulatory documentation• Integrating automation, CI/CD, and modern engineering practices into regulated environmentsI am particularly interested in the responsible use of AI within regulated medical device software development. I have introduced governance frameworks that define how, where, and when AI tools can be safely used in SaMD development workflows while maintaining traceability, validation integrity, and regulatory compliance.These initiatives have improved engineering productivity by over 25% while maintaining strict audit readiness and verification standards required for regulated healthcare software.I enjoy working at the intersection of digital health innovation, regulatory compliance, and engineering leadership to help organizations build safe, scalable, and compliant healthcare technology.Areas of expertise include:Digital Health Architecture | Software as a Medical Device (SaMD)| Regulated SDLC | ISO 13485 | IEC 62304 | ISO 14971 | FDA Software Compliance | CE Marking | MDSAP | Design Controls | Verification & Validation | Risk Management | AI in Regulated Software Development | DevOps & CI/CD | Engineering Leadership
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