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Proof of medical benefit in the form of an expert opinion (case studies) is mandatory for certain medical devices to become registered in the German Health Aid List (Hilfsmittelverzeichnis – HMV). Qualitative appropriate medical assessment and specific parameters are necessary to prove the product’s medical benefit. This applies, for example, for orthotics / splints, therapeutic exercise equipment, bandages, mattresses among other devices.

These expert opinions are not equivalent to Clinical Evaluations for CE documentation. Expert appraisal is a special request for German reimbursement by the statutory health insurance funds. Naturally, the expert appraisal can be used as a literature source for Clinical Evaluations.

Due to many years of experience and contacts with health-care institutions and professionals, BEO BERLIN® is able to create respective expert opinions within reasonable time.

  • Clinical trial protocol
  • Network of medical experts
  • Test centre selection
  • Clinical trial monitoring
  • Written report

 

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