Showing items tagged as Medical Device

  • Modernizing the FDA's 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 2

    19 December, 2018 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.

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  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 1

    12 December, 2018 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This blog post is the first of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. Part 1 discusses key points of the ICIJ investigation on the medical device industry, the FDA’s response, and the implications of this hot-button public debate in the near future.

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  • De Novo Becoming Faster and Easier Pathway to Market

    25 October, 2018 by David Jensen, Staff Writer, MasterControl

    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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  • BraveHeart Team Emphasizes Quality-First Approach

    16 October, 2018 by David Jensen, Staff Writer, MasterControl

    One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.

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  • Getting Paid: A Shifting Medical Device Reimbursement Landscape in Australia

    9 October, 2018 by Sarah Griffin, Principal Consultant, Brandwood Biomedical (Australia)

    Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.

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  • Med Device Company Takes Flight With Life-Changing Innovation

    3 October, 2018 by David Jensen, Staff Writer, MasterControl

    Startup ventures are the embodiment of innovation – often hitting the ground running with little more than an idea and a vision. Part one of this three-part series introduces startup medical device company, BraveHeart Wearable Life Sensors, and how it is uniquely inspired by aviation.

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  • How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry

    26 September, 2018 by David Jensen, Staff Writer, MasterControl

    The countdown to the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) deadlines is underway. However, transition issues are creating a logistical logjam for both the medical device industry and the European Commission (EC), which is impacting the med device industry. MedTech Europe still wants the EC to stop the clock.

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  • New Digital Pathways Boost Success Rate of Med Device Introductions

    25 September, 2018 by David Jensen, Staff Writer, MasterControl

    Launching a med device always has a sense of urgency. However, failing to gain market approval or facing a recall can be costly. You avoid these scenarios with new digital pathways that facilitate faster and more efficient regulatory information management (RIM) and product life cycle development.

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  • The Globalization of Clinical Data in Medtech

    18 September, 2018 by Danielle Giroud, Founder and CEO, MD-Clinicals (Switzerland)

    Regulatory agencies are increasingly demanding prospective clinical data as part of the clinical evidence for medical device market access. That is increasing the costs borne by manufacturers. The silver lining: the acceptance of foreign data by those agencies, including China, is also on the rise.

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  • Pregnancy and Medical Device Submission Management: Can the Pain Be Reduced?

    29 August, 2018 by Marci Crane, Staff Writer, MasterControl

    At first glance, the processes of human pregnancy and medical device submission management are as “non-workable” as peanut butter and cinnamon or popcorn and ketchup. However, it’s surprising how many pains these two forms of labor have in common.

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  • Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    9 August, 2018 by David Jensen, Staff Writer, MasterControl

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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  • How to Gain Entry to Latin America’s Medtech Market

    7 August, 2018 by Julio G. Martinez-Clark, CEO, LATAM Market Access

    Don’t get bit by piranhas and crocodiles when entering Latin America’s lucrative $31 billion medical device manufacturing industry. Learn from a pro the tips, strategies and trends you’ll need to be successful in the golden medtech market in North and South America.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • How AI Tools Will Transform Quality Management in the Life Sciences, Part 2

    12 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers. Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.

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  • How AI Tools Will Transform Quality Management in the Life Sciences, Part 1

    10 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.

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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 2018 by James Jardine, Staff Writer, MasterControl

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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