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TSG Consulting recently hosted a panel discussion exploring the process of registering new products in these categories. Before we go on to highlight five key questions that industry posed to our panel, we start with taking a look at the regulatory...
Article
April 27, 2021
Senior Regulatory Consultant, Dr. Om Singh, was published in the February 2020 issue of the Journal of Medical Device Regulation. An analysis of the US FDA’s draft guidance on nitinol-containing medical devices, and the reasons for its development...
Article
February 7, 2020
The significance of correct substance identification under the Biocidal Products Regulation (EU) No. 528/2012 (BPR) is often underestimated. However, inaccuracies can cause knock-on effects on other parts of the dossier and subsequent processes. In...
Article
February 4, 2020
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