Software to manage regulatory workflows for medical device development at academic medical centers: A critical gap

• Lynn Rose,
• Jennifer McCaney,
• Gaurav Dave,
• Kimberly A. Brownley,
• David Sheridan,
• Payal Shah,
• Grzegorz Zapotoczny,
• Juan Espinoza

Affiliations

Lynn Rose

Department of Pharmacy, University of Washington, Seattle, WA, USA

Jennifer McCaney

Anderson School of Management, University of California Los Angeles, Los Angeles, CA, USA

Gaurav Dave

ORCiD

Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA North Carolina Translational and Clinical Sciences Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA Center for Health Equity Research, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Kimberly A. Brownley

ORCiD

North Carolina Translational and Clinical Sciences Institute, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA Department of Psychiatry, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

David Sheridan

Department of Emergency Medicine, Oregon Health & Science University, Portland, OR, USA

Payal Shah

West Coast Consortium for Technology & Innovation in Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA Division of General Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA

Grzegorz Zapotoczny

ORCiD

West Coast Consortium for Technology & Innovation in Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA Division of General Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA

Juan Espinoza

ORCiD

West Coast Consortium for Technology & Innovation in Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA Division of General Pediatrics, Children’s Hospital Los Angeles, Los Angeles, CA, USA Department of Pediatrics, Keck School of Medicine of USC, Los Angeles, CA, USA