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.

MDSAP and ISO 13485:2016 Quality Auditing, Audit Prep, and Audit Support, Audit Defense

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.

Clinical Evaluation Reports (CER)

MEDDEV 2.7/1 Rev 4

Clinical Literature Search

State of the Art Search

Regulatory Post Market Surveillance Review

Qualifications and Certifications

RAC Certified

Certified ISO 13485 Lead Auditor

Six Sigma Yellow Belt Certified 

Graduate Degree Educated (MHA & MPA)

Gap Analysis

Regulatory Gap Analysis

CER Gap Analysis

MDSAP Gap Analysis

ISO 13485:2016 Gap Analysis

CE Mark Gap Analysis

EU MDR 2017/745 Gap Analysis