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The Path Forward: Retooled Technical Doc TR 24971 Guides Device Firms On Risk Management Standard ISO 14971

 
• By Shawn M. Schmitt

When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.

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What happens when you develop a guidance document for an international standard, but not many people use it? That's the conundrum the International Organization for Standardization (ISO) faced after it published Technical Report 24971 in 2013.

TR 24971 offers manufacturers guidance on risk management standard ISO 14971. The TR is currently undergoing its first update in...

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