Medical Devices Regulatory Strategy and Market Access Consulting

  • Overview
  • Services
  • Experts
  • Why Work With NSF?

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. Our medical devices consulting professionals have former FDA and industry experience and provide your company a hands-on, personal and comprehensive approach to help you navigate regulatory challenges and efficiently meet regulatory requirements throughout the product lifecycle.


Our consultants bring the right level of expertise with custom solutions to guide you through:

Medical Devices Regulatory Strategy

  • Regulatory approval, clearance and registration strategies for market access, including product classification and borderline products
  • Premarket notification 510(k) consulting
  • ISO 14155 clinical evaluation reports
  • Preclinical testing support, including design control documentation development
  • Clinical trial strategy and design support
  • Postmarket clinical follow-up and surveillance

Medical Devices Regulatory Interactions

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

Medical Devices Regulatory Support and Submission

  • Preparation and review of IDE, PMA, de novo, 510(k) consulting, design dossier and technical files
  • Response to review deficiencies
  • Clinical evaluation reports and systematic literature reviews
  • Filing of supplements and/or reports for device changes and regulatory compliance


Our medical devices consulting staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices to help our clients achieve sustainable and compliant quality systems.

Why Work With NSF?

NSF maintains a commitment to outstanding service and quality. We focus on your business objectives through the use of sound science and proven expertise. Initial consultations are provided as a professional courtesy. Our expertise covers a wide range of therapeutic areas, product types and regulatory specialties.

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