France, Belgium, Switzerland, Singapore.
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.