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Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971

 
• By Shawn M. Schmitt

It’s time for manufacturers to begin adopting the new 2019 version of ISO 14971, the international standard for risk management widely used by industry. But firms need to do more work than just changing the date on risk-related procedures and documents to “2019,” says Jos Van Vroonhoven, a senior manager at Philips Healthcare who was intimately involved with the standard’s redo. From conducting gap assessments to creating cross-functional teams, both Van Vroonhoven and longtime industry expert Don Powers tell Medtech Insight how firms can keep their quality systems up-to-date to conform to ISO 14971:2019.

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From gap assessments to cross-functional teams, device makers must take targeted steps to update their quality systems and procedures now that ISO 14971 – the international standard for risk management widely used by industry – has been revised.

That’s just one tip from a Philips Healthcare expert who was intimately involved with the latest revision of ISO 14971, published by the International Organization for Standardization (ISO).

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