Donawa Lifescience believes in quality, not quantity. What does that mean to you? For Donawa Lifescience it means that we treat each project in a tailored fashion, to provide solutions that are adapted to the tasks that need to be performed or managed in order to commercialise your medical device, in vitro diagnostic (IVD) or combination product.
Italy - UK - USA
Quality
Donawa Lifescience holds an EN ISO 13485:2016 certificate from Bureau Veritas Italia, demonstrating its commitment to providing the highest quality services to its clients. The scope of the certificate is:
“Provision of medical device, in vitro diagnostic device, and drug/device combination product clinical research (CRO), regulatory and quality system services for European and United States regulatory compliance, and European Union Authorized Representative services for medical device, in vitro diagnostic device and drug/device combination product manufacturers.”
This scope covers all services the company provides for its clients, including:
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.
