ADN
Country headquarter:
France.
Market presence:
France, Belgium, Switzerland and Singapore.
General description:
Consulting and services for Computer System Validation (Pharma and Medical Device).
Dassault Systèmes integrator for Medical Device 3DExperience (PLM): Device History File, Device Master Record, Quality, Regulatory (including UDI).
HP Integrator (Quality Center for paperless validation with e-signature).
Areas of regulatory/reimbursement support:
Digital Product LifeCycle Management, Medical Device Consulting.
21 CFR Part 11, 21 CFR PART 820, Quality Management System (ISO 13485), Software standards (IEC 62304); Computer Modeling and Simulation for Medical Device; Virtual Commissioning; Requirement Management, Risk Management ( ISO 14971 ), Document Management.
Company website
https://ec.europa.eu/digital-single-market/en/ehealth-and-ageing
The eHealth Hub project has received funding from the European Union’s Horizon 2020
Research and Innovation Programme under Grant Agreement No727683.