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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  • 2018-bl-thumb-top-med-device-trends-asia-pacific

    2019 Med Device Trends: Digital Health Will Move Onward

    If this year’s Consumer Electronics Show (CES) is any indication of things to come, we can expect the role of medical devices in digital health to move onward and upward. The popular annual trade show attracted over 500 exhibitors of digital health products, including hundreds of medical devices.

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  • business-icons-digital-touchboard-132

    Regulatory Changes Top the List of 2019 Med Device Trends to Watch For

    If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way. The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.

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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-vaccine_132x132

    Medtech Startups: How to Survive Cutthroat Competition

    In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

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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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  • 2021-bl-qarad-eifu_132x132

    Regulatory Strategies for AI and Emerging Technologies

    Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.

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