Node ADN

ADN

 

Country headquarter:

France.

 

Market presence:

France, Belgium, Switzerland, 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

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