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Experts at Johner Institute
Professor Johner and his team of software professionals, auditors, and risk managers respond within 48 hours (except weekends).
  • 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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