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