Dr. Kalpesh Hegde
Medical Device Operations and Regulatory Affairs in Helsinki
Dr. Kalpesh Hegde holds wide experience in the Diagnostic industry developing systems product and handling Gobal Operations, currently residing in Helsinki, Finland Dr. Hegde expertise in setting up plants in Medical device IVD Industry and for diagnostics projects
Dr. Kalpesh Hegde is an alumni of BITS Pilani, Hospital and Health Systems Management, graduated from the Rajiv Gandhi University of Health Science, Bangalore, also holds a PG in Hospital and Healthcare Management from All India Institute of LSG, Mumbai, he holds various professional certifications including Six Sigma Green Belt specialized in Healthcare Operations and is lead auditor for ISO 13485 : 2016, PMP, ISO 9001:2015 Quality Lead Auditor, and Lean Facilitator,
Dr. Kalpesh Hegde holds 10+ years of experience in Operational Excellence, Quality Assurance and Regulatory Affairs within the medical device & IVD industry, specializing in Point of Care, Immunoassay, HPLC LCMS/MS and Class 3 Devices, across regions including Asia, Europe,Japan, NAMER, Middle East My expertise includes ISO 13485 compliance, risk management (ISO 14971), and regulatory submissions (FDA, CE Marking).