Our services

Biotika ® offers you its expertise in technical and regulatory assistance on medical devices.
In fact, our engineers of regulatory affairs are able to deliver you a risk analysis, the answers to the essential requirements, the list of applicable standards, a technical file of the medical device and the practice of the regulatory intelligence in accordance with the Directive 93/42 CEE.

Moreover, our engineering skills in physics and electromechanical measurement allow us to assist you for optimizing your devices.


We are able to offer you our services in the technical, pre-clinical and clinical validation of your prototypes:

  • Test validation of medical devices
  • Test on bench test (automated measurement campaign for qualifications)

 

Linked to the risk analysis of medical devices, we can fulfill aging studies, reliability studies, comparative tests, dimensional tests.

We own:

  • Remote data acquisition cards by the Labview software
  • A precision balance to + / - 0.01 g
  • Infusion devices
  • Ball force sensors
  • And other devices for monitoring and measurement

 

A pro-forma estimate may be based on your needs. Contact us at the following address: contacts@biotika-isifc.com

Publications

parution : 08/06/2016

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Our partners
CIC Centre d'investigation Clinique de Besançon
/www.fc-sante.fr/cic-besancon/
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