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Lakshman Prakash Balajepalli
Head of Regulation and Quality at RAS Lifesciences


A Master of Sciences (Biochemistry) from a prestigious medical school in India. Over 28 years’ experience in Lifesciences industry (IVD and Human vaccines) which includes in over 20 years in IVD industry in R&D, manufacturing, QC, QA , Regulatory as well as of 8+ years’ experience in process development, QA of human vaccines. Highly experienced in Regulatory, QMS including ISO 13485, ISO 9001, ISO 15189 systems.

Experienced in many WHO and GMP audits. Has extensive experience in Indian MDR and QA as well as in EU IVDR, EU-MDR, Invited Speaker on Validations (site, laboratory, process), Regulatory rules and on EU-IVDR, Design development, Risk Management for medical devices

Agenda Sessions


  • Guidance on the Classification Process for IVDs