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EAS Services for Medical Devices

EAS Consulting Group, LLC is a leading provider of regulatory services to the medical device, pharmaceutical, food, dietary supplement, tobacco, and cosmetic industries. Whether your product is a class I, II or III device, EAS Consulting Group, LLC. has the expertise to provide wide-reaching guidance as well as act as a conduit between manufacturers and marketers of devices and FDA. No matter the type of device, whether your company is in need of a 510(k) Premarket Clearance, IDE, QSR audit, US Agent or registration assistance or the filing of petitions, exemptions and responding to warning letters and 483s, EAS can help. Choose EAS for

  • Regulatory Strategy Development
  • Regulatory Compliance
  • 510(k) Pre-Market Clearance, De Novo and PMA submissions
  • ISO 13485 QSR and FDA GMP harmonization
  • CAPA, FDA 483 & WL Remediation
  • Facility and SOP Audits
  • Label Assistance
  • Design History and Device Master Files
  • Seminars and Onsite Trainings
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