CRO services: Study design and review (EN ISO 14155 compliance), biostatistics, site qualification and initiation, site monitoring, site close out, study report writing or review.
Clinical regulatory services: Ethics Committee (EC) / Institutional Review Board (IRB) and Competent Authority / FDA Investigational Device Exemption (IDE) submissions, adverse event reporting, site agreement negotiation.
Device, IVD and combination product regulatory services: Clinical Evaluation Reports (CERs), CE marking, US FDA premarket approvals (PMA) and premarket notifications (510(k)s), Pre-Subs, EU MDR/IVDR transition and compliance.
Quality system services: EN ISO 13485:2016 compliance, US FDA 21 CFR 820/803/806 compliance, MDR quality system requirements.
EU Authorised Representative (AR) services: Providing non-EU companies with a liaison to the national Competent Authorities, including vigilance and field safety corrective action (FSCA) reporting.