ARTICLES BY BOB MARSHALL

  • 3 Bad Ideas For FDA Pre-Sub Meetings
    2/27/2017

    The FDA currently handles about 1,500 pre-subs per year - a number expected to grow to about 2,350 in the next five years. Here I present three sure-fire ways to make your pre-sub meeting stand out for all of the wrong reasons. 

Bob-Marshall-headshot

Bob Marshall

Bob Marshall served as Chief Editor for Med Device Online between December 2016 and December 2018, during which MDO benefited from his more than 20 years of experience in medical device product development, manufacturing, quality assurance, and regulatory affairs. He spent the previous seven years with medical device consulting firm Regulatory & Quality Solutions and held leadership positions with Renal Solutions (now Fresenius Medical Care), Siemens Medical Solutions, Medrad (now Bayer HealthCare), and Respironics (now Philips Healthcare). He holds both a BS in electrical engineering and an MS in organizational leadership from Geneva College.