You need a management representative with oversight over medical device quality.
A company statement aims to set the record straight.
Perhaps the organizational soul searching should begin after receiving one Form 483.
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.
The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.
Ernst & Young’s Pulse of the Industry report is out, and once again, it’s not all gloom and doom.
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
Regulations, cost pressures drive medical device companies to innovate.
Device manufacturers are concerned about data availability and security, as well as risk to their brand.
As medical device companies move technology concepts into the commercialization stage, collaborating with outside partners is crucial.