Regulatory affairs

Medical device and in-vitro diagnostic companies of every size and therapeutic area look to NSF’s regulatory affairs and market access team to bring innovative healthcare products to market.

The company’s team of professionals with former US Food and Drug Administration (FDA) officials and an extensive industry experience provides your company with a hands-on, personal, and comprehensive approach to help you navigate regulatory challenges and efficiently meet regulatory requirements throughout the product lifecycle.

NSF’s consultants bring the right level of expertise with custom solutions to guide you through:

Regulatory strategy

  • Regulatory approval, clearance, and registration strategies for market access, including product classification and borderline products
  • Premarket notification consulting
  • Preclinical testing support, including design control documentation development
  • Clinical trial strategy and design support
  • Post-market clinical follow-up and surveillance

Regulatory interactions

  • Communications with the FDA, notified bodies, and other regulatory authorities
  • Pre-submission meetings and scientific briefings
  • FDA advisory panel meeting preparation and expert panels

Regulatory submission and support

  • Preparation and review of investigational device exemption (IDE), pre-market approval (PMA), de novo, design dossier, and technical files, as well as 510(k) consulting
  • Response to review deficiencies
  • Clinical evaluation reports and systematic literature reviews
  • Filing of supplements and reports for device changes and regulatory compliance