Brindusa Curcaneanu – Cybersecurity and Quality and Regulatory Advisor / Consultant

Brindusa Curcaneanu is a Quality & Cybersecurity leader with 25+ years of experience across medical devices, pharmaceuticals, and biopharma, specializing in AI-enabled medical devices, regulatory compliance, design controls, and risk management. She brings deep expertise across the Total Product Lifecycle (TPLC), spanning ISO 13485, IEC 62304, ISO 14971, FDA QSR, EU MDR, and MDSAP, with a strong track record of translating regulatory expectations into practical, audit-ready execution.

She has extensive experience in embedding Secure-by-Design principles into design controls, software lifecycles, and AI/ML systems. Her work spans cybersecurity risk management, SBOM lifecycle governance, AI-specific hazard analysis, model-change controls, PCCPs, and post-market surveillance, aligned with FDA, NIST AI RMF, EU AI Act, and international best practices.

Brindusa is a core contributor and co-author of the Health Sector Coordinating Council (HSCC) AI Secure-by-Design Guide and Playbook for Medical Devices, helping shape industry guidance at the intersection of AI safety, cybersecurity, and regulatory compliance. She is an active participant in HSCC and CISA task forces, collaborating with regulators, manufacturers, and policy leaders to advance scalable, risk-based frameworks for connected and intelligent medical technologies.

Brindusa presented at HIMSS 2025 on pre-negotiated cybersecurity provisions for medical device contracts, addressing how manufacturers and healthcare providers can proactively manage cyber risk, regulatory expectations, and contractual accountability.

A committed mentor and people leader, Brindusa is actively involved with Women in Cybersecurity (WiCyS), supporting the development of the next generation of cybersecurity and quality professionals. Known for her ability to lead cross-functional teams, strengthen quality systems, and operationalize complex regulations, she champions practical, defensible processes that accelerate safe, compliant innovation.