Nilaykumar Patel

Background

About Nilaykumar Patel

Executive Summary: Results-driven leader in quality and regulatory affairs with 15+ years of international experience in AI/ML-regulated medical device software, startup mentorship, and quality management systems. ISO/IEC TC 62 Technical Expert contributing to European standards for Software as a Medical Device (SaMD). TÜV-certified Quality Auditor with deep expertise in EU MDR, FDA 510(k), MDSAP, and cybersecurity compliance (GDPR, HIPAA, ISO 27001, IEC 81001-5-1). Proven track record of scaling regulatory operations from the ground up, leading cross-functional teams to achieve zero non-conformity audits, and advising startups on market access strategies across multiple jurisdictions.Key Expertise:Regulatory & Compliance: EU MDR 2017/745 | FDA 21 CFR 820 & 510(k)| MDSAP | ISO 13485:2016 & 14971 | IEC 62304, 82304-1, 62366-1Business & Leadership: Strategic roadmap development | Cross-functional team leadership | Startup regulatory mentorship | Market access & investor readinessCybersecurity & Risk Management: IEC 81001-5-1 | GDPR | HIPAA | ISO 27001 | Threat modeling & risk assessmentQuality & Audit: TÜV-Certified Internal Quality Auditor | QMS design & implementation | MDSAP audits | Internal & notified body auditsISO/IEC Standards Development: TC 62 Technical Expert | Contributing to international standards for AI/ML-SaMD (Data Governance, PMS)With never give-up attitude, dedication and unshakable strong will, I have always succeeded in resolving complex issues in my career.I always keep pushing myself beyond my own limitations which boost me to reach to new career heights in whatever the role or position I am assigned to!