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Historic, references, key people

MEDIMARK® EUROPE has been created early 1995 by René Clement and Philippe Leglise in order to fulfil the need for non- European Manufacturers of Medical Devices to designate an official European Authorized Representative such as requested by the MD Directive and reinforced by the IVD Directive.

The focus on this activity has allowed MediMark® Europe with the help of Competent Authorities, to build tools and procedures which are recognized as the gold standard for product notification, incident reporting and recall organization.

MediMark® Europe is the first European Authorized Representative to be ISO 9001 certified for this specific activity. It allows Manufacturers to prove to their Notified Body that their European Vigilance System is also under a Certified Quality System.

Key people who work for the highest professional services to our customers are:

René CLEMENT, CEO / President, with his background in Clinical Affairs, Epidemiology and Business management. He takes care of General Management, Regulatory compliance and Vigilance.

Lynette HOWARD, as US Partner of MediMark Europe makes contract proposals, helps our customers for building the Technical Files and, from her extensive Experience in EU Quality Standards for medical devices, provides extra-services to answer to regulatory questions. Lynette is the author of several books regarding ISO 13485.

Christine TERRIER, as Quality Affairs and Finance Manager takes care of General Management, Regulatory compliance and Vigilance. Since she is in permanent relation with European competent authorities, she has a deep knowledge of specific EU NCAs requirements for Field Safety Corrective Actions and follow-up of Incident Reportings.

Reference list from Customers :Since 1995, responses from Customers show full satisfaction and we are proud to continue to serve well known Companies, even after they have been bought by large groups. They recognize that MediMark Europe offers much more than an "European address". A reference list is supplied on request.

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