David Vidal Email & Phone Number

Rochester, Minnesota, United States

Rochester, Minnesota, United States

Rochester, Minnesota, United States

Rochester, Minnesota, United States

• Former General Counsel, Chief Compliance Officer, & SVP for Quality Assurance & Regulatory Affairs• Helped ensure that AI medical device systems meet the quality, regulatory, legal, and ethical standards to be safe, efficient, and equitable for patients throughout the lifetime of the device• Oversaw, monitor, and maintain the implementation and effectiveness of the compliance program• Improved infrastructure and streamline policies & procedures for regulated AI at scale•… Show more • Former General Counsel, Chief Compliance Officer, & SVP for Quality Assurance & Regulatory Affairs• Helped ensure that AI medical device systems meet the quality, regulatory, legal, and ethical standards to be safe, efficient, and equitable for patients throughout the lifetime of the device• Oversaw, monitor, and maintain the implementation and effectiveness of the compliance program• Improved infrastructure and streamline policies & procedures for regulated AI at scale• Contributed to and comment on publications related to AI research, policy, regulation, and ethics• Spoke at national AI medical device events including those sponsored by the American Medical Association, American Bar Association, law firms, AI policy consortiums, and academic meetings• Tracked national quality, regulatory, and legal trends related to AI and medical devices• Oversaw international compliance, including foreign regulatory approvals, Foreign Corrupt Practice Act compliance and export/import compliance• Led sales and marketing compliance activities, including procedures, approvals, and training for anti-kickback statute, fraud and abuse, and FDA labeling• Managed corporate compliance activities • Aided outside counsel in corporate conversion and investment rounds• Oversaw contract drafting, negotiation, and approvals • Aided in the drafting, development, and administration of AI medical device clinical trials• Represented the company at in person meetings with FDA • Oversaw the drafting and submission of FDA Submissions • Represented management during 3rd party audits• Coordinated the AI device real world monitoring activities, including regulatory reporting compliance• Conducted and manage internal audits covering 21 CFR 820, European Directive 93/42/EEC, ISO 13485, MEDDEV Guidelines, HIPAA, GDPR, and Clinical Trials.• Held lead Auditor Certificate for ISO 13485• Contributed to the maintenance of HIPAA and GDPR policies and procedures Show less

Sacramento, California Area

• Researched and drafted legal memoranda in multiple practice areas including education, public agency, criminal law, contracts, and employment law.• Prepared and analyzed research in areas including corporate filing, insurance, immigration, district reorganization, and internet privacy law. • Drafted motion for summary judgment

Stanford, Ca

Assistant Coach and Recruiting Coordinator• Helped coach two NCAA Division 1 Cross Country National Championship Teams and 75 All-American performances• Coordinated five years of top-five nationally ranked recruiting classes • Directed the Stanford Cross Country High School Camp• Instructed a running techniques and training class at Stanford University• Wrote the article Improving Steeplechase Results, the cover story in the February 2011 distribution of TECHNIQUES… Show more Assistant Coach and Recruiting Coordinator• Helped coach two NCAA Division 1 Cross Country National Championship Teams and 75 All-American performances• Coordinated five years of top-five nationally ranked recruiting classes • Directed the Stanford Cross Country High School Camp• Instructed a running techniques and training class at Stanford University• Wrote the article Improving Steeplechase Results, the cover story in the February 2011 distribution of TECHNIQUES MAGAZINE. Show less

Education record

Visiting Student Honors: Deans Award for Academic Excellence in Introduction to Intellectual Property (2014)

Doctor Of Law (Jd)

Activities and Societies: Law Review Three legal publications: Startup Immigration: Stimulating Startup Communities with Immigrant.

Bachelor Of Arts (Ba), Human Biology

Activities and Societies: Varsity Track & Field; Varsity Cross Country Cross Country Team Co-Captain (2005)

Education record