The disgraced company founder Holmes and its former President Sunny Balwani have been charged with raising more than $700 million from investors in a massive fraud scheme.
Failure to comply with FDA’s wishes landed three companies warning letters.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Throughout 2018, device and diagnostic manufacturers have opportunities to address challenging market trends and turn internal change into ways of increasing business and goodwill from providers who purchase their technology.
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
Many device manufacturers don’t have the resources to adequately handle security risks.
These three practical methods can help facilitate success.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
The addition will further expand IPC’s event capabilities.
It’s good news for device companies, but industry associations and stakeholders are still seeking a permanent solution.