Management declaration
Management declaration
« The ‘Authorized Representative’ is defined as any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the MDR & IVDR Regulations ».
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 its Customers the highest quality of services for meeting customer/MME contractual provisions and requirements from the EU regulations and National Competent Authorities (NCA) regarding the CE Marking of medical devices.
Our Quality System covers the following processes as European Authorized Representative:
– Management Process
– Contract Process
– Technical Process (Technical Documentation, EUDAMED, Vigilance)
– On-line regulatory assistance
– Financial Business management
The objectives of this quality management system are:
– To assist our customers in answering to the requirements of the European Regulations by maintaining the highest level of expertise in European Regulatory Affairs
– To continually follow-up the efficiency of the Quality System Processes for the satisfaction of our customers and to fulfill the expectations of the EU Competent Authorities.
Periodic Management Review Meetings include establishment and review of the achievement of the company quality objectives. During a meeting, the Management Declaration is reviewed for continuing suitability.
A copy of this Declaration is made available to all staff members via the computer system
Grenoble, November 14th, 2023
René CLEMENT
President- C.E.O.,
MediMark Europe SARL