Rucha Patel

Quality Assurance and Regulatory Affairs Manager, MIMOSA Diagnostics Inc.

Ms. Rucha Patel is an experienced Quality Assurance and Regulatory Affairs Professional with over 07 years of strong Regulatory Compliance and Regulatory Submission experience with exposure in start-up, small and large businesses in compliance with US FDA, Health Canada, European Union, ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820, 21 CFR Part 11, MDSAP, GMP, GCP, GLP, and ICH Guidelines requirements. Through her strategic thinking and risk-based approach, she has been able to develop effective Quality Systems within the Clinical Trial, Pharmaceutical and Medical Device Industries.