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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, Co-Chairman, with his background in Clinical Affairs, Epidemiology and Business management. He takes care of General Management, Incident Analysis and Reporting.

Philippe LEGLISE, Co-Chairman, Industrial Pharmacist, Microbiologist with more than 20 years experience in diagnostic and medical devices, worldwide recognized expert, he has participated to the elaboration of numerous European standards.

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.

Christine TERRIER, as Financial and Quality Manager of MediMark Europe takes care of invoicing, general administration and follow-up of our ISO 9001 certification.

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.

Referral list of Consultants, Translation Companies & others :

ELS (France), Alain Ruiz. Assistance to the IVD Manufacturers for developing a European Distribution Network.

Brand Consulting Group Inc (USA)., Leigh Brand, Quality and Regulatory Compliance.

Q & RC, Larry Potter (USA), Quality and Regulatory Compliance.

International Regulatory Consultant (USA), Donald Grabarz, Quality and Regulatory Compliance, U.S. designated agent for non U.S. companies.

Global Language Solutions (USA), Expertise in multilingual translation of medical and pharmaceutical documents

Additional information on these companies can be obtained by contacting us.

The other consultants working with MediMark® Europe may be listed after giving their written approval.

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