Cadence Regulatory uses over 30 years of medical device industry and consulting experience to help you address the regulatory requirements in order to grow your business. We will:

• Design a regulatory strategy to get your product successfully to market

• Write, submit, and guide through the FDA process:

  • 510(k)s

  • Investigational Device Exemptions (IDEs)

  • Pre-Market Approval applications (PMAs)

  • De Novo applications

  • Combination product submissions

  • Requests for Designation

  • Letters to File

  • Device Master Files

  • Freedom of Information Act (FOIA) requests

  • Breakthrough Technology applications

  • STeP applications

  • Pre-Sub / Q-Sub applications

• Strategic and tactical consultation on working with regulating authorities

• Clinical literature article review and editing prior to publication

• FDA User Fee and Small Business Exemption applications

• FDA establishment registrations and device listings

• Review of device labeling, package inserts, user manuals, web sites, videos, and marketing literature for regulatory compliance, clarity, and market advantage