ADN Compliance IT for Pharma and Medical Device, Product Life Cycle management  

MEDICAL DEVICES 

• FDA and CE compliance 

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

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• Requirement Management

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

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• Product LifeCycle Management FDA

PHARMACEUTICAL INDUSTRY 

• Validation of computerized systems 

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• Compliance FDA - Data Integrity - 21 CFR PART 11
   

• Project Management - Change Management 

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• Digital Validation - Cloud - Mobile

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• RPA / CA 

REQUIREMENT MANAGEMENT

• Consulting - Services - Training 

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• Requirements Engineering 

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• Reqtify Expert and Traceable Requirement Management Dassault Systèmes 3DExperience 

SYSTEMS ENGINEERING

• Consulting - Services - Training 

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• Systems Engineering 

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• System Architect Expert Dassault Systèmes 3DExperience 

Cloud

• Consulting - Services - Training 

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• Compliance

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• AWS Partner