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 An analysis of the US FDA’s draft guidance on nitinol-containing medical devices, and the reasons for its development...

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...

TSG Consulting, a leading regulatory and scientific consulting organization, says it is now more important than ever to develop a robust compliance strategy that considers all Brexit scenarios to ensure market access post-transition. “Whilst the...