Full Service for your Quality, Regulatory, Auditing and Compliance Needs

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Regulatory and Quality Assessments

Allow us to Assess your Regulatory and Quality needs.

Quality Auditing, Audit Prep, and Audit Support

Allow us to Audit your Quality System, prepare you for your next external audit, and support you during your next external audit.

Regulatory Submissions and Registrations

510(k) Submissions to FDA, Pre-subs, Establishment Registrations, PMA Support, Notified Bodies, Device Listings, UDI, International Registrations (Latin America, Asia, Eastern Europe, Middle East), EU CE Marking and Tech File/Design Dossier Creation and Maintenance, FDA US Agent Services.

Qualifications and Certifications

RAC Certified

Certified ISO 13485 Lead Auditor

Six Sigma Yellow Belt Certified 

Graduate Degree Educated (MHA & MPA)