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
Certified ISO 13485 Lead Auditor
Six Sigma Yellow Belt Certified
Graduate Degree Educated (MHA & MPA)