With offices in the U.S. and Europe, MDCI is positioned to help you interface efficiently with international regulatory bodies and meet the regulatory requirements for your device or diagnostic product. Our U.S. and European resources will help you meet individual country requirements and EU requirements to obtain the CE mark under the Medical Device and IVD Directives. We can also manage and monitor your European medical device clinical trials.

KEY CE MARK CONSULTING SERVICES

Developing and Implementing Product-Specific Strategies for Worldwide Product Introductions

Assess applicable Medical Device Directives and individual country requirements

Preparing for CE Marking

Product classification and essential requirements determination

Labeling reviews

Risk management

Design Dossiers and Technical Files

Liaison with Notified Bodies and Competent Authorities

Developing and Implementing Quality Systems to Meet Applicable ISO EN 9000 and EN 46000 Series Quality Standards

Auditing against Medical Device Directives and essential requirements

Assisting with Clinical Investigations to Meet Multi-National Requirements and Conformance with ISO 14155 and U.S. FDA GCP Requirements (See Clinical Services)

Functioning as European Authorized Representative

Assisting in Vigilance Reporting