Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on ...

State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing ...

Expediting regulatory guidance for RWE in medical devices: Why it matters for patients Real-world evidence (RWE) can enhance our understanding of the safety, performance, and effectiveness of medical ...

Medical device manufacturers can face regulatory problems for a variety of reasons, Matthias Kaeser, Principal & Owner at Kaeser Associates, recently told MD+DI. Most of these have to do with ...