dimarts, 5 d’agost del 2014

Medical device makers find new layer of regulation before earning CE Mark approval | Regulatory news for the week of August 4, 2014




Here's a look at some of the top regulatory stories for medical device companies this week: Medical device makers face new obstacles to European approval; FDA panel narrowly OKs Cohera Medical's TissuGlu; FDA cuts fiscal 2015 user fees; Catching up with the FDA's 2014 guidance; FDA panel votes against EDAP's ultrasound prostate cancer ablation






Medical device makers face new obstacles to European approval


July 30, 2014 by Arezu Sarvestani


Medical device makers face new obstacles to CE Mark

Cohera Medical Inc., EDAP TMS SA, European Commission, Food & Drug Administration (FDA)

News Well, Regulatory/Compliance

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