• The MDR Evolution: A Quick Guide to Medical Writing Under New Regulation

    6 days ago - By Boston Biomedical Associates

    For those MedTech innovations sold or exported into Europe, the path to regulatory approval has grown much longer and more complex. A thorough and comprehensive set of standards, known as the Medical Device Regulation , has replaced a much less stringent set of guidelines, known as the Medical Device Directive. MDR is four times longer than MDD with a host of new classifications, and it sets high expectations for more demanding data collection and more rigorous post-market follow-up.
    What does this mean? This means it is time for your regulatory strategies to progress into the future, and...
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