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