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Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group. Read More
Proposed changes to the way the FDA considers risks and benefits of 510(k) devices could undermine the efficiency and predictability of the popular market clearance route, a lead industry attorney says. Read More