Harmonization

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?

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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