Speakers
Sruti Lahkar
Session 2: Building Sustainable Quality Systems and Inspection Readiness
Hosted by Ankita Joshi, RAPS SF
Sruti Lahkar is a quality and design assurance leader with more than 10 years of experience across the medical device and pharmaceutical industries, with expertise in SaMD, AI/ML, and digital health. She currently serves as Senior Quality Lead at Genentech (Roche), where she supports quality frameworks for investigational medical devices and software.
Her experience spans the quality management system (QMS) lifecycle, including design controls, risk management, supplier quality, CAPA, complaint handling, and audit readiness. She also serves as a member of the AAMI TIR 115 Working Group and holds an MS in Biomedical Engineering from the University of Southern California.
Ankita Joshi, MS, is a Regulatory Affairs Specialist at ReCor Medical with more than four years of experience navigating the medical device industry. With a background in biomedical engineering and healthcare management, she supports regulatory strategy and compliance with U.S. FDA and EU MDR requirements.
In addition to her role at ReCor Medical, Ankita serves as the Device Programming Committee Leader for the RAPS San Francisco Bay Area Chapter. She leads the development and organization of regional events for Silicon Valley’s regulatory community and is committed to fostering collaboration on emerging industry trends.
:
ankitajo