Achieving success in India involves patience and a firm grasp on the culture and regulatory environment.
In order to keep innovation and manufacturing in the United States, device companies need federal and local support.
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.