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Medical device 510(k) premarket notifications: sometimes slow and steady wins the race

As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major...

Medical device 510(k) premarket notifications: sometimes slow and steady wins the race

As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major...

News archive

Meet the professionals – January spotlight

Kelly leads an important sector of TSG’s work – state affairs. With the experience gained from working for over 30...
Article January 07, 2022

An overview of FDA’s premarket regulation of medical devices

FDA’s legal and regulatory framework The definition of a medical device FDA’s risk-based classification of a device...
Article December 07, 2021

Biopesticides, Plant Growth Regulators, and Biostimulants: 5 questions about the US regulatory framework answered

TSG Consulting recently hosted a panel discussion exploring the process of registering new products in these...
Article April 27, 2021

Analysis of the US FDA’s draft guidance on nitinol-containing medical devices

Senior Regulatory Consultant, Dr. Om Singh, was published in the February 2020 issue of the Journal of Medical Device...
Article February 07, 2020

BPR: 5 steps to correct substance ID

The significance of correct substance identification under the Biocidal Products Regulation (EU) No. 528/2012 (BPR) is...
Article February 04, 2020