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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
Certified ISO 13485 Lead Auditor
Six Sigma Yellow Belt Certified
Graduate Degree Educated (MHA & MPA)
Regulatory Gap Analysis
CER Gap Analysis
MDSAP Gap Analysis
ISO 13485:2016 Gap Analysis
CE Mark Gap Analysis
EU MDR 2017/745 Gap Analysis