This offending company has “significant” violations regarding reporting corrections and removals to FDA.
China’s medtech influence is beginning to threaten the West’s dominance.
Energy is something we take for granted as we use it for surgery, but surgical energy is about to make its mark. Those who ignore what’s happening will be left behind.
If your firm does not have an MDR procedure, FDA will find out.
Documentation proves compliance, including when it comes to acceptance activities.
In addition to tax incentives in China, U.S. manufacturers are seeking Chinese partners due to a lack of domestic funding.
Failure to investigate complaints is a major compliance failure.
Although not as stringently controlled as medical devices, veterinary devices fall under FDA’s authority. And the agency is watching.
When device modifications could affect safety and effectiveness, a premarket notification submission is required.
Tariffs on imports will hurt business expansion in Asia.