Meet Us
Seema S. Singh, Principal Consultant and Founder
Seema Singh is highly skilled in medical device compliance and is the Lead Consultant at Conscious Consulting Solutions. She has over 11 years of experience as a Field Investigator at FDA in the San Francisco District Office.
Seema’s expertise as an FDA Certified Medical Device Investigator involved finding, investigating, and collecting evidence for quality system deficiencies at a variety of different device facilities in the U.S., as well as throughout Europe, China, Japan, and Taiwan as part of the foreign inspections team. Her inspectional work included pre-market approval recommendations, compliance follow-up and risk-based inspections, and investigating trade complaints, adverse events, and recalls. She investigated numerous high-profile companies, most notably being one of the initial investigators at Theranos, which prompted several federal agency investigations and ultimately led to guilty verdicts for the company’s CEO. Her other work at FDA resulted in recommendations for prosecution, injunction, civil money penalties and numerous warning letters.
Throughout her FDA career, Seema has been engaged in training and supervising FDA investigators. In her final years at FDA, she served as a subject matter expert, mentor and presenter for FDA’s National New Hire Training course for incoming investigators stationed throughout the U.S.
Seema has an M.S. in Mechanical Engineering, with an emphasis in Design, and a wide array of FDA specific training in areas such as design control, process validations, industrial sterilization, inspection of x-ray and laser facilities, and conducting international inspections.
Contact Seema
+1 (650) 418-0512
www.linkedin.com/in/seemassingh
