MEDICAL DEVICES
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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
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Validation of computerized systems
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Compliance FDA - Data Integrity - 21 CFR PART 11
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Project Management - Change Management
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Digital Validation - Cloud - Mobile
REQUIREMENT MANAGEMENT
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Consulting - Services - Training
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Requirements Engineering
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Reqtify Expert and Traceable Requirement Management Dassault Systèmes 3DExperience
SYSTEMS ENGINEERING
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Consulting - Services - Training
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Systems Engineering
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System Architect Expert Dassault Systèmes 3DExperience