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Technical File documentation on PMS in line with MDR

MDR requirements are complemented by harmonized standards EN ISO 13485 and EN ISO 14971. In addition to the pre-market assessment of risks associated with a new device, EN ISO 14971:2012 specifies requirements for production and post-production information to be considered as part of the overall risk assessment process throughout the life of the device.

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Proactive

  • Customer surveys
  • Post CE mark clinical trials, including PMCF
  • Manufacturer sponsored device tracking/implant registries
  • Expert user groups (focus groups)

Reactive

  • Customer Complaints
  • Unsolicited user feedback (other than complaints)
  • Maintenance/service reports
  • In-house testing (routine)
  • Failure analysis
  • Social media
  • Literature reviews
  • Regional or national device registries (non-manufacturer sponsored trials)

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