A highly proficient Medical Devices professional and a leader with variety of skill sets in Quality assurance and Regulatory Affairs. I have over 10+ years of experience working for Fortune 500 companies in United States. I along with my team provide consulting services for Medical Devices manufacturers in the field of Quality Assurance & Regulatory Compliance. Our services range from EU MDR/ IVDR Compliance, Risk Management solutions per ISO 14971, Design Controls per 21 CFR 820, Product & process validations, Test method validations, IEC 62304 compliance, 510k filings, Complaints handling, DHF Remediation, New Product Development and Engineering change management.