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MEDICAL DEVICES 

  • FDA and CE compliance 

  • Advice and Services IEC 62304, ISO 13485, 14971, 62366 

  • Requirement Management

  • Design History File, Device Master Record, Quality, Regulatory

  • Product LifeCycle Management FDA

PHARMACEUTICAL INDUSTRY 

  • Validation of computerized systems 
  • Compliance FDA - Data Integrity - 21 CFR PART 11
     
  • Project Management - Change Management 
  • Digital Validation - Cloud - Mobile 

REQUIREMENT MANAGEMENT

  • Consulting - Services - Training 
  • Requirements Engineering 
  • Reqtify Expert and Traceable Requirement Management Dassault Systèmes 3DExperience 

SYSTEMS ENGINEERING

  • Consulting - Services - Training 
  • Systems Engineering 
  • System Architect Expert Dassault Systèmes 3DExperience 

Cloud

  • Consulting - Services - Training 
  • Compliance
  • AWS Partner