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.
Company’s Keywords:
vigilance & mdr reporting, ce marking, strategic regulatory affairs, clinical evaluation reports, 510 clearance, interpretation of standards, meddev 271 rev 4, clinical documentation, australia clinical approvals, design assurance, mdr in europe, pma approval, ide approval, prrc, due diligence, regulatory approvals & global device registrations, technical writing, competent authority & ethics approvals, efs study approval fda, risk management, clinical investigation brochures, post approval activities
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