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MediMark Europe Quality Policy

Management declaration

« Authorized Representative means the natural or legal person established in the Community who, being explicitly designated by the Manufacturer, acts and may be addressed by Authorities and Bodies in the Community in substitution for the Manufacturer with regard to the latter’s obligation ».

MediMark® Europe was the first European Company of Regulatory Affairs which has set up, in 1995, the standards of Authorized Representative’s activities and is since 1998, certified to ISO 9001 in order to provide services in continuation with the quality system requirements of his Customers.

It is the policy of MediMark® Europe to provide these Customers with the highest quality of services for meeting contractual provisions and requirements and set up in accordance by the relevant Notified Bodies and Competent Authorities (C.A.) for the CE Marking of medical devices.

Our Quality System covers the following types of activity as European Authorized Representative::
-  Proposal & finalization of Customer contracts
-  Technical File review, maintenance and Product notification to the French Competent Authority
-  Management of vigilance issues
-  On line regulatory assistance

The objectives of this quality management system are:
-  To continually improve the services provided by updating permanently its awareness of European Regulatory Affairs through a regular review of the European legislation and direct contact with national Competent Authorities of the European Economic Area as needed.
-  To continually improve the processes by which the services are supplied with the commitment to be in compliance with the legal and EU regulatory requirements.

Periodic Management Review Meeting includes establishment and review of the achievement of the company quality objectives. During this meeting, this Quality Policy is reviewed for continuing suitability

A copy of this policy is made available to all staff members via the computer system

Grenoble, 2016-09-29

René Clément and Philippe LEGLISE

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