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 ...



parution : 08/06/2016

View all publications
Our partners
Matrix Requirements
see all our partners
Virtual Firm as a Role-Playing Tool for Biomedical Education
see the file
Flyer Biotika
see the file
see all downloads