I am Abhinav Singh, an accomplished Software Quality Engineer with over nine years of specialized experience in the medical device and healthcare technology sector. My expertise lies in Software as a Medical Device (SaMD), AI/ML integration in medical device development, cybersecurity risk management, and regulatory compliance. Currently, I serve as a Staff Software Quality Engineer at iRhythm Technologies, where I lead software validation and regulatory strategies to ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and the EU AI Act. Professional Contributions & Achievements ✔ Industry Leadership & Contributions Recognized speaker at ICAIN 2024, presenting "Enhanced Rehabilitation and Therapy using AI: A Future Approach" (Springer publication). Actively involved in the development and compliance of AI-driven medical technologies, ensuring alignment with regulatory frameworks. Contributor to ASQ’s Software Division and Medical Device Working Groups, shaping industry best practices for software validation and risk assessment. ✔ Regulatory & Compliance Expertise Extensive experience in SaMD validation, cybersecurity risk mitigation, and post-market surveillance. Lead strategic initiatives to integrate Design Failure Mode and Effects Analysis (DFMEA) with cybersecurity risk mapping to enhance medical device safety and reliability. Strong background in ensuring compliance with global regulatory frameworks including FDA 21 CFR Part 11, 803, 806, 820, HIPAA (45 CFR Part 164), ISO 27001, EU MDR, and the EU AI Act. ✔ Recognition & Certifications ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE). Excellence in Quality Assurance Award – Medtronic, 2018. Invited judge/moderator for The MedTech Conference 2025. Reviewer and contributor to software and cybersecurity standards for medical devices. ✔ Research & Innovation Published multiple articles and research papers on AI in healthcare, risk-based quality assurance, and cybersecurity in medical devices. Developed AI-driven predictive maintenance models for medical device manufacturing, enhancing reliability and operational efficiency. ✔ How I Can Help You I am open to consulting, speaking engagements, and advisory roles in the fields of: 🔹 AI and Medical Device Innovation 🔹 Regulatory Compliance & Risk Management 🔹 Cybersecurity for Medical Devices 🔹 Software Validation & Process Automation 🔹 Career Guidance in MedTech & SaMD Development Feel free to connect with me to discuss collaborations, speaking opportunities, or professional insights.