Just Because You’re Trained, Doesn’t Mean You’re Competent
Orthopaedic device manufacturers must define the requirements for each job, evaluate the people in those jobs, develop a gap examination...
Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex...
The FDA is only the latest regulatory body to take investigative action on metal-on-metal implants. What follows is a two-part...
Additive manufacturing is expected to be a $3.5 billion industry by 2017. Orthopaedic device manufacturing has the ability to grow...
FDA's final rule on cGMP for combination products provides a definition of these products and the new requirements....
ASTM added a PEKK raw material standard for medical device implants that if met, will reduce the testing needed to...