Showing items tagged as Medical Device

  • 5 Keys to Helping Your Device Company Gain MDSAP Certification

    2 January, 2019 by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

    The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.

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  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    2 January, 2019 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

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  • 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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  • Advancing the Case for Quality in Medical Device Manufacturing

    18 October, 2018 by Stephanie Christopher, Program Director, Medical Device Innovation Consortium

    We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.

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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 Evolution of Medical Device Clinical Trials, Part 2

    20 September, 2018 by James Jardine, Staff Writer, MasterControl

    Regulatory shifts and global advancements are reshaping the way medical device companies approach their clinical trials. Learn about the present state of medical device regulatory compliance and envision the future of the clinical landscape for devices.

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  • The Evolution of Medical Device Clinical Trials, Part 1

    19 September, 2018 by James Jardine, Staff Writer, MasterControl

    Medical devices face a unique set of challenges during the course of clinical trials. Get an insightful look into the regulatory standards that affect medical device clinical trials and learn how clinical trials for devices are significantly different from – and often more flexible than – those of drug products.

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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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  • Keeping Up With Regulatory Changes for Medical Devices

    4 September, 2018 by Michelle Lott, Principal and Founder, Lean RAQA

    Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.

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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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