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Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
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