Aditya Kulkarni

About

IVDR/MDR Consultant, UK Responsible Person, SaMD specialist, AI in Healthcare, Lead Auditor, DHF specialist With 15 years of experience in the Medical Device and Pharmaceutical industries, I have honed my skills in various Regulatory and Quality functions. My strong business acumen is complemented by a focus on Regulatory and Quality compliance. I possess expertise in New Product Development and Project Management, built on a solid technical foundation. I have worked with different regulatory bodies and successfully navigated regulatory audits. Specialties: MDR/IVDR 510K Medical Devices UK Responsible Person ISO 9001 Lead Auditor ISO 13485 Auditor Technical File Review Risk Management and Cybersecurity SaMD (Software as a Medical Device) and AI (Artificial Intellegance) CER (Clinical Evaluation Report) DHF (Design History File) PMS (Post-Market Surveillance) UDI (Unique Device Identification) Label and IFU Artwork Review Device Global Registration Medical Device Product Testing