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Showing items tagged as medical device innovation

  • 2021-bl-transitioning-ivdr_132x132

    Challenges with Transitioning to the EU In Vitro Diagnostic Devices Regulation

    The deadline for the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) is about a year away, and if you haven’t started preparing, now is the time. Understand the challenges you might face during the process and what you can do to address them.

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  • smart-document-contract-132

    De Novo Becoming Faster and Easier Pathway to Market

    There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.

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  • 2020-bl-compliance_132x132

    Top 5 Trends That Will Shape the Medical Device Industry in 2018

    At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.

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