Clinical Affairs

Our service offering in clinical affairs

Biotika offers you to:

- Conduct the clinical evaluation of your medical devices (according to MEDDEV: draft 2.7/1 review : 4)

  • Literature review
  • Demonstration of equivalence 
  • Demonstration of clinical evidence 
  • Report writing of clinical evaluation

- Conduct the clinical investigation of your medical devices according to ISO 14155

  • Preparing the Clinical investigation plan
  • The calculation of the number of needed subjects
  • Preparing the required documents:  investigator's brochure, clinical report file ...

 

Publications

parution : 08/06/2016

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Innov'Health
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Cisteo medical
www.cisteomedical.com
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