Medical Device Regulatory Affairs Consulting

  • Overview
  • Benefits of Regulatory Consulting
  • Why Work With NSF?
  • Core Regulatory Affairs Services

NSF International provides international regulatory consulting services including FDA and EU expertise to support the development, marketing, regulation and stewardship of medical devices, including in vitro diagnostics and combination products. Our core specialty is the development and execution of strategic efforts to support pre-market approval and post-market requirements. Our clients are multinational companies, mid-size and small firms, privately held companies, investors and outside regulatory and litigation counsel.

Benefits of Regulatory Consulting

Benefits of our international regulatory affairs consulting services include:

  • Widely-recognized senior professionals with former leadership positions in international regulatory agencies (FDA and EU) and the industry 
  • Expert staff with detailed knowledge of industry best practices, especially within quality systems, product development and early-stage ventures
  • Proven record of success with complex assignments and unique, innovative products
  • Global regulatory expertise that spans many product types: from high-risk implants to non-traditional device types (such as gels and injectables) to routine-use and home-use devices (such as drug-delivery systems)
  • Broad network of subject-matter experts across all therapeutic areas
  • Total product lifecycle perspective that builds quality into regulatory affairs

Why Work With NSF?

We maintain a commitment to outstanding service and quality, and we focus on achieving your business objectives through the use of sound science and proven expertise. Initial consultations are provided as a professional courtesy. We can assist across a wide range of therapeutic areas, product types and regulatory specialties.

Core Regulatory Affairs Services

We offer a wide range of regulatory consulting services, including:

  • Regulatory consultation: Product classification, regulatory strategy, unique and combination products, due diligence and emerging regulatory issues
  • Regulatory submissions:  IDE, 510(k), PMA, 513(g), European CE marking in Class III medical devices, and post-marketing submission support (PMA supplements, 510(k)s for device changes, annual reports, and post-market studies)
  • FDA and European agency interactions: Pre-510(k) and pre-IDE meetings and competent authority scientific briefings, advisory panel preparation and support, dispute resolution and administrative appeal
  • Clinical study design and evaluation:  Patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts, and publication development
  • Global regulatory filings

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