According to a 2017 medical device industry survey, “Regulatory changes continue to represent the biggest business challenge to most survey respondents.” Let Regulatory Compliance Associates® Inc.’s team of experts guide you through the constantly changing domestic and international regulations to successfully register your medical devices.

 

Global Regulatory Strategies

As your U.S. Agent, we provide assistance with U.S. FDA establishment registration and device listing services for your medical device product(s).

  • International Regulatory Strategies
  • Product Classifications
  • FDA 513(g) Request
  • International Registration

Pre-Submission Support

  • Preparing and Conducting Pre-Submission Meeting with FDA
  • Regulatory Strategy
  • Evaluation of ISO 13485 and FDA Compliance

Domestic and International Submissions Services

  • Technical Writing [510(k) submissions, PMA submissions, De Novo, Technical Files, Clinical Reviews, Explanation Letters, etc.]
  • Submission Preparation and Filing with Regulatory Authorities
    • Pre-Market Notification (510(k))
    • Pre-Market Approval (PMA)
    • Innovative Regulator Pathways (i.e., De Novo)
    • Humanitarian Use Device (HUD) and Device Exemption (HDE)
    • European Union Technical Files and Class III Design Dossiers
  • Facilitation and interaction with regulatory authorities

Post-Submission Services

  • FDA Establishment Registration and Device Listing
  • U.S. Agent Services

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