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It's A Green Light For ISO 13485: Revised Global Quality Systems Standard Finally Published

This article was originally published in The Gray Sheet

Executive Summary

After five years of high-stakes development, ISO 13485:2016 was published on Feb. 24. The 36-page worldwide quality systems standard carries an official publishing date of March 1, which means firms have until March 1, 2019, to comply.

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ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to "gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming," TC210 delegate Kim Trautman says. The survey closes Nov. 9.

QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 'In The Coming Years,' Official Says

The US agency's 22-year-old bedrock rule for making safe and effective medical devices to be sold in the United States will likely be replaced with international quality systems standard ISO 13485, FDA official Sean Boyd said at MedCon 2018. But the author of the Quality System Regulation, Kim Trautman, told Medtech Insight that it would be a thorny, years-long chore for the agency.

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