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| With
offices in Paris (France) and Almere (The Netherlands) and 9 associate
partners in 12 countries, The Visual Consultancy
Corporation is positioned to efficiently interface with worldwide
regulatory bodies and to meet international medical device and diagnostic
product requirements. Our qualified European staff offers assistance
in meeting individual country requirements and EU requirements to
obtain CE marking for medical devices under the Medical Device Directives
and managing and monitoring European clinical trials. Auxesia provides comprehensive international services including: Developing and Implementing Product-Specific Strategies for Worldwide Product Introductions
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Design
and execute reimbursement strategies
Developing and Implementing Quality Systems to Meet Applicable ISO EN 9000 and EN 46000 Series Quality Standards
Assisting with Clinical Investigations
to Meet Multi-National Requirements and Conformance with EN 540
and U.S. FDA GCP Requirements |
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