Regulatory/Quality assistance

Our service offering in regulatory assistance 

The team of Biotika’s regulatory affairs offers: the conduction of the regulatory monitoring within your company, to accompany you in your projects, the choice of notified bodies and procedures in order to obtain the CE marking.

Biotika undertakes to achieve the technicals files of your medical devices according to STED format (GHTF/SG1/N063: 2011):

  • Medical device classification
  • List of relevant standards
  • Method of manufacturing (Flowchart, …)
  • Process validation
  • Operating manual
  • Results of design calculation (qualification reports)
  • Risk analysis according to EN ISO 14971  standards
  • Essential requirements response according to 93/42/CEE directive
  • Label and IFU

Some examples of what Biotika® can do:

  • Participate in software validation by answering the specific requirements of EN 62304: 2006.
  • Prove the suitability of your medical devices (according to EN 62366: 2008).


Our service offering in quality assistance

The team Biotika’s quality offers you:

  • Quality management system according to ISO 13485 v 2016
  • Conduct you internal audit
  • Build your quality documentation




parution : 08/06/2016

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