Sonoma Pharmaceuticals (SNOA) has completed transition to the new European Union Medical Device Regulation for four of its products in Europe. Sonoma was granted classification as a Class IIb medical ...
Medical devicemakers in the European market are one step closer to securing a bit of breathing room after saying new regulatory laws could lead to product shortages among their businesses. The ...
Currently, both existing CE-mark devices and devices hoping to be sold in the European Union (EU) face major challenges in the conformity assessment procedure for market access. During his session, ...
A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe ...
The European Union’s Medical Device Coordination Group (MDCG) continues to churn out guidances for the new Medical Device Regulations (MDRs), but there are several nagging questions about devices ...
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its certification under the EU ...
Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...
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