Simplifying Global Compliance
Report Details Risk Management Needed to Conform to EU’s MDD, Annexes Z
International Medical Device Regulatory Monitor
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.
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