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Prior art search and non infringement studies
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Invention disclosure
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Voice of the Customer methodology (VOC)
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Users Requirements Analysis to define Uses Specifications
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Device System and Sub-system analysis
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Risks Management
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Prototyping and Bench Testing
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Design Reviews
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Verification & Validation, Design Transfer
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Project Management fulfilling Medical Devices Regulations:
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Design Control and DHF filing
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Definition of Regulatory Affairs data from Design
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Regulatory Strategies in EU and RoW
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Global Regulatory Consulting for Medical Device and IVD
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Regulatory Gap Analysis
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Creation of a Regulatory Dossiers
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Global Medical Device Registration and Approval
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EC Representative service (AR)
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US agent service