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