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ISO 13485 Confirmed until 2024

  • Posted by: inetika
  • Category: GLOBAL NEWS

Good news for medical device manufacturers has emerged from the ISO/TC 210 meeting that took place in London during week commencing 7 October 2019, in that the Technical Committee took action to confirm ISO 13485:2016 for an additional standard period (five years), until 2024. The ballot was nearly unanimous with just one vote for revision and 33 votes to confirm, with 7 abstentions.

For once, regulators, industry groups and member bodies have all come together in common agreement to give the medical device industry some stability in the area of quality management system (QMS) requirements for the next five years.