Report Details Risk Management Needed to Conform to EU’s MDD, Annexes Z

International Medical Device Regulatory Monitor
A A
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.

To View This Article:

Login

Buy This Article Now

Add this article to your cart for $40.00