clinical evidence

Clinical Evidence

Clinical Evidence Insights for Medical Devices in China

Registration of medical devices in China requires a clinical evaluation report (CER) regardless of the device classification. For many, preparing a CER that meets China’s requirements is a daunting challenge...
Uncertainty

Risk vs. Benefit FDA guidance gets to grips with uncertainty

Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...

Search

Recent Posts

Categories

Categories

Archives

Archives

Archives