ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
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EU MDR Technical File and PMS Documentation

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.

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)

Additional Resources

  • Read More about Technical File / Design Dossier >>>

  • Details about Medical Device Post Market Surveillance. Click Here >>

  • Details about Post Market Clnical Follow Up (PMCF). Click Here >> 

  • Details about Periodic Safety Update Report (PSUR). Click Here >>

  • PMS and QMS (ISO 13485) relationship in line with MDR. Read More >>>  

  • Details about Post Market Surveillance Plan and Procedure. Click Here >>  

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