FDA Outlines Stance on ex-U.S. Clinical Data
In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval...
It is critical for all companies to establish and properly train their own IP police force to enforce their own...
Orthopaedic device manufacturers can benefit from outsourcing services such as inventory management, warehousing, order processing and shipping, thus freeing up...
Here, we present highlights from a variety of technologies cleared and launched during 2014 and 2015 across traditional and biologic...
ichard Randall, recently appointed CEO of OMNI, plans to drive growth by expanding the company’s robotics portfolio and targeting new...
On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new...