Harmonization

Why Perform a Gap Analysis?

Why Perform a Gap Analysis?

‌  As new technologies continuously push the limits of medical devices and drugs, regulations and governing...

FDA Approves Comirnaty

FDA Approves Comirnaty

‌  The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for...

ISO 13485 & QSR Harmonization

ISO 13485 & QSR Harmonization

For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...

The USMCA Agreement

The USMCA Agreement

FDA played a key role in the negotiations of the United States-Mexico-Canada Agreement. The agreement entered into...

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