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Medical devices

We have the people and the plans needed to assist you to make the right decisions for a successful entry of medical devices into the market.

Medical devices encompass a wide range of products. Today, there are more than 500,000 medical devices on the European market. Some are closely regulated and need extensive clinical documentation, whereas others have a classification that makes the path to CE marking and market access shorter.

For medical device clients we have established a dedicated team with experience and competence with the regulatory requirement from the different phases in the product development; from evaluation of the CE classification, creating documentation and clinical evaluation report to interaction with Notified Body. We have experience in planning, conducting and reporting of studies for medical devices as well as expertise to undertake health economic evaluations.

Our medical devices consulting include, but are not limited to:

Medical device requirements

                European and national regulatory requirements

                Product/Risk Classification

                Guidance for regulatory processes

                Risk management

 
Quality Management System (QMS)

               Quality systems & Quality assurance

 

Documentation

               Create CE EU Technical File/Design Dossier

               Medical writing

               Review labeling and user documentation

               User-testing

 

Clinical

               Clinical evaluation report

               Clinical study documentation

               Data management

               Statistics

 

Health economy evaluation

                
               Health economics analyses


 

Purchasers of medical devices, such as public hospitals, are subjected to strict budgetary control. With limited resources all purchases of new medical equipment are carefully considered. Health economic analyses can help manufacturers elucidate and clarify for the buyer the economic benefits of the new medical equipment.


More about medical device

Download Medical Device flyer  

Updated

Related contacts:

1737 cropped hp Lars
Lars Guntveit
Global Director Medical Device 
Norway
Tel:+47 92 44 92 00
lars@linkmedical.no
280x180- Jan
Jan Hellqvist
Managing Director
Sweden 
Tel: +46 70 913 51 25
jan@linkmedical.se
0314amarianne
Marianne Holst
Managing Director
Denmark
Tel:+45 22 15 85 56
marianne@linkmedical.dk
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Uwe Anzenberger
General Manager
Germany
Tel:+49 176 8227 0156
      +49  30 2461 2025
uwe.anzenberger@linkmedical.de