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AR-QUALI's will accompany you in all your projects on time or more systematically.

You have an idea, a project in the biomedical field, and you don't know where to start.

We will take the time to a State of play of your project, your structure, your strategyand your goals to bring you the solution that will best meet your requirements andyour constraints. Depending on your needs, we can accompany you on different aspects:

CE MARKING FOLDER

  •     Identification of applicable regulatory requirements
  •     Identification of harmonised technical standards to take into account
  •     Development of your specification
  •     Mastery of design
  •     Identification and management of risks in accordance with EN ISO 14971
  •     Identification of tests and tests to carry out
  •     Clinical evaluation in accordance with the MEDDEV guide
  •     Response to the essential requirements
  •     Records of validation processes
  •     Operating instructions, labelling, packaging
  •     Assistance in the drafting of the CE marking folder
  •     Compilation of the technical file of synthesis STED
  •     Helps in the formation of the product folder
  •     Assistance in the drafting of declarations of conformity


CE marking folder