Anita Ramachandran has over 25 years’ experience in Medical Device Industry working as Regulatory and Quality Consultant. She is part of EIS-Medical Device Group working for Regulatory solution CoE. She helps in providing consultancy on various geography specific regulations and guidance, software process standards, verification & validation, security assurance, Software as Medical Devices and Digital Health program. Anita’s specialization includes Quality Management, Regulatory Strategy definition, Risk Management, CSV / OTS Validation, Software / System Verification and Validations, Project Remediation’s, Process improvements, DHF / Design Dossier Creation, 510 (K) / Technical File Submissions, Audits and Training. Her present focus is on keeping abreast with the regulations around the digital health program, cybersecurity in Health IT. Anita also guides in development of In-house Tools, framework / Methodology and PoCs in medical device regulatory space.