The Decus team is comprised of experienced professionals
– with strong technical backgrounds and industry experience.
Grace Bartoo, Ph.D., RAC, CBA – President and Chief Executive Officer
Grace is the founder of Decus Biomedical and has led this company for the past 15 years which has helped over 100 medical device companies achieve their goals. She has more than 35 years of experience in the medical device industry, including research, clinical, regulatory and management experience in a wide variety of medical device and in-vitro diagnostic types with a particular expertise in software. She has spent over 15 years working directly in medical device start ups and has helped bring companies from initial funding to full operations. Grace leads a team of high-qualified quality, regulatory and clinical personnel in providing consulting services for a wide variety of projects including: preparation of regulatory strategy, FDA presubmission meetings and premarket regulatory applications; Design History File and Device Master Record preparation; preparation and execution of multi-site clinical studies; establishment and improvement of Quality Systems; conduct of formal Quality System audits and leading FDA/NB inspections; development and execution of device verifications and validations, and software tool validation to comply with 21 CFR 11 and process validation requirements . Grace has also served on an FDA advisory committee, IEEE Engineering in Medicine and Biology board, is a Regulatory Affairs Society Fellow and is certified in regulatory affairs (RAC) and biomedical quality auditing (CBA). Grace received a Ph.D. in Bioengineering and an MS in Electrical Engineering from University of Washington where she focused on medical image analysis. She continues to participate with academic centers and is currently on the external advisory board for the University of Washington Bioengineering Department and the Stanford Biodesign Digital Health Advisory Council.
Terri Bogucki, M.S. – Product Development Specialist
Terri has undergraduate degrees in Electrical Engineering and French from the University of Notre Dame and a M.S. in Biomedical Engineering from UC Davis. She has over 20 years’ experience in medical devices, working to define, develop, launch and market products in medical specialties as diverse as radiology, radiation oncology, pulmonology and gastroenterology. Terri has also been involved in business development, clinical studies, writing IPOs and research. Since joining Decus in 2012 Terri has helped establish quality systems, guided risk management teams, led usability study efforts and helped write regulatory submissions.
Jennifer Malhotra – Quality Engineer
Jen has 14 years of experience as a HW Engineer and a QA Test Engineer. Jen spent ten years working in consumer electronics in both QA functions within manufacturing and has demonstrated ability to bring up new QA processes and streamline manufacturing operations and reduce costs. She has demonstrated design engineering capabilities in board design. Jen turned her attention to medical devices with joining Decus Biomedical 5 years ago and applies her expertise is in designing in executing HW and SW verifications and validations in conformance to IEC 62304, 21 CFR Part 11, 21 CFR Part 820.30 and ISO 13485. Jen has a double B.S. in Electrical Engineering and Materials Science.