Johner Team

Ask an expert: Experts answer to your specific and crucial questions

Ask an expert: Experts answer to your specific and crucial questions

Get answers and help, absolutely free and with no obligation

Do you have questions or need help with:

  • Classification of your products,
  • Market approval process (e.g. Europe/CE-marking or US/FDA)
  • Development of an ISO 13485 or FDA compliant QMS,
  • Writing documentation for market approval (e.g. the risk management file, the software file (software architecture, software requirements specification, ...), design history file, clinical evaluation, etc.)
  • Or the preparation of an audit or a "CE Certification"?

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