Are You Ready for EU MDR? Only 24 Months to Go!

At the MedTech Forum 2022 in Barcelona, there was a tense and “standing room only” moderated session on the looming May 26, 2024 EU Medical Device Regulations (MDR) implementation deadline.  Representatives from the notified bodies, competent authorities, industry, and other trade groups had a very intense interchange about the deadline, which requires all companies selling […]

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The Future of Us

As our world spins toward the highly anticipated “new normal,” pharma and related industry conferences in the last few months have shown us that the new normal will be anything but business as usual.  Instead, we are witnessing an accelerated adoption of advanced new technologies that many of us had previously associated with the IT […]

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Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and […]

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