Regulatory

Utilizing proven methods to improve quality and regulatory systems we are able to update your quality system ensuring it is compliant with FDA and EU Regulations. We provide submission services, pre-market services, market entry services and maintenance services.

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Regulatory services include:

  • Audits and audit readiness (GMP/QSR, MDD/ISO 13485)
  • Risk Management ISO 14971
  • ISO 13485 Certifications
  • Compliance to 21 CFR Part 820
  • Gap analysis
  • Design History Files
  • Design Dossiers
  • Quality Procedures
  • 510K Submissions