When to Contract Your Device Testing
All medical devices must be tested. However, the varied aspects of device testing can be unfamiliar ground, and standards are...
In efforts to invigorate revenue growth, Medtronic and Zimmer Biomet have focused on niche technologies that expand their portfolios—but have...
Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported...
FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier....
Vagueness in standard methods and regulatory guidance surrounding instrument testing and validation has left OEMs questioning what best practices to...
TSO3 completed sterile efficacy validation for multiple heavy-duty battery-powered orthopaedic instrument sets in a single sterilization cycle. ...