Rupesh Nigadkar

Background

About Rupesh Nigadkar

17 years’ experience in implementing best practices for Regulatory and Quality compliance. Quality Management, Lead Auditor ISO13485 & ISO 9001, Six Sigma Lean Process implementation, Regulatory Affairs & Compliance, Manufacturing Excellence & Lean, Customer Quality Medical Device Process Improvement, FMEA/APQP/CAPA/SCAR & Strategic Quality.A Six Sigma Black Belt handling corporate Quality and regulatory affairs function for Philips India Limited. Proficient at managing Quality and Regulatory Function in APAC. Experience in developing and implementing Quality, regulatory, customer and business excellence strategies.Expertise on Implementation of ISO 13485 2016 / ISO 9001 2015, USFDA 21 CFR 820. 510K,Medical Device rules 2017 (India), European IVD Directive 98/79/EC and IVDR (IVDR 2017/746), Good Manufacturing Practices, GLP, GDP, High Level Risk management tools as per FMEA and ISO 14971, D&C Act 1940, D&C Rules 1945 (Products/ Warehouses), Medical Device Single Audit Program (MDSAP), WHO GMP, PQ, India GMP (Good Manufacturing Practices as per Global Guidelines),Post Market Surveillance Strategies (IVDR/ India MDR 2017),Compliance to Essential Principles, Clinical Performance Evaluation as per MDR 2017 (CDSCO).