About Aztec Medical
Aztec Medical have been offering regulatory, design assurance and clinical consulting services to the medical device industry for over 20 years. Offering both remote and on-site support, we ensure that your needs are met in the way that best suits you.
Headquarters
Galway City, GalwayWebsite
http://www.aztecmedical.comCompany Size
11-50 employeesIndustry
Business Consulting and ServicesCompany Type
Privately HeldFounded
-Specialties
Strategic Regulatory Affairs, Regulatory Approvals and Global Device Registrations, MDR in Europe, Post Approval Activities, Technical Writing, Design Assurance, Risk Management, Clinical Evaluation Reports, Clinical Documentation, EFS Study Approval: FDA, IDE Approval, Clinical Investigation Brochures, Vigilance and MDR Reporting, Competent Authority and Ethics Approvals, CE Marking, 510(k) Clearance, PMA Approval, Australia Clinical Approvals, Interpretation of Standards, Meddev 2.7.1 Rev 4, PRRC, Due Diligence, Biocompatibility, and Sterility Assurance