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New medical device team

LINK Medical can assist you with a successful entry of your medical device into the market.

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 services for medical devices 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

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

Contact us for more information about Medical Device services

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