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More about Medical devices 

LINK Medical has built up expertise within regulation and documentation of medical devices. The gained experience from completed and ongoing projects enables us to give customers the services needed to document their systems and their devices on the right level. We work closely with the customer to achieve the agreed targets.

At LINK Medical we have the competence to assist medical device manufacturers in compilation of clinical data that proves the safety and effectiveness of a medical device, and also document the health economic value of your device.

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

 Also see more on Health Economics

 

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.

 

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