clinical evidence

Winding Road

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

As the long-awaited deadline for the implementation of the European Medical Devices Regulations (EU MDR) finally draws near, it is now more important than ever to understand the applicable deadlines...
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Technical File Differences Between Medical Devices and IVD Medical Devices

With the Medical Device Regulations (MDR) coming into force from 26 May 2021 and the upcoming In Vitro Diagnostics Regulations (IVDR) from 26 May 2022, the regulatory requirements are finally...
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...

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