Sim Narasimhan
About Sim Narasimhan
Biotechnology executive with 25 years of experience leading quality assurance, operations, product development and R&D efforts for large-scale enterprises and high-growth startups. Passionate about developing innovative life science products and building great teams. Extensive experience in the establishment, certification and sustaining of quality systems, 21 CFR 820 Quality System Regulation, cGMP, ISO 13485 Medical Devices – Quality Management Systems, ISO 9001, Medical Device Risk Management (ISO 14971), existing product and process cGMP compliance (Class II and Class III devices), regulatory compliance, software and non-software product development and design control, quality leadership of multiple sites, FDA inspections (including PAI), Medical Device Single Audit Program (MDSAP), Supplier Quality and strategic planning for CLIA/CAP labs for the VALID Act regulation of LDTs.