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summary technical documentation

What is the STED Format for Medical Device Technical Documentation?

EMERGO SUMMARY OF KEY POINTS:

  • Summary Technical Documentation (STED) was developed to drive more standardization of medical device regulatory submissions across markets.
  • STED is recognized by US, European, Canadian, Australian and Japanese regulators, as well as in other markets.
  • The International Medical Device Regulators Forum (IMDRF) has been planning updates to the STED format, but there is little progress to report thus far.