Aditya Kulkarni
Managing Director @Sushvin Consultancy Services
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WORK HISTORY
Managing Director @Sushvin Consultancy Services
EDUCATION
University of Greenwich
Master's degree
Indira college of Pharmacy
Bachelor's, Pharmacy
ABOUT ADITYA KULKARNI
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/IVDR510KMedical Devices UK Responsible PersonISO 9001 Lead AuditorISO 13485 AuditorTechnical File ReviewRisk Management and CybersecuritySaMD (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 ReviewDevice Global RegistrationMedical Device Product Testing
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