• 2018-bl-thumb-medtech-europe-urges-european-commission

    How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry

    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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  • 2018-bl-thumb-regulatory-new-digital-pathway

    New Digital Pathways Boost Success Rate of Med Device Introductions

    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

    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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  • 2018-bl-thumb-globalization-clinical-data

    The Globalization of Clinical Data in Medtech

    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

    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?

    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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  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

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

    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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  • 2018-bl-thumb-medtech-entry-in-latin-america

    How to Gain Entry to Latin America’s Medtech Market

    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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  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    Regulatory Barriers to Innovation for Startups

    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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  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-2

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

    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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  • 2018-bl-thumb-how-ai-tools-transform-quality-mgt-in-life-sciences-part-1

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

    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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  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    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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  • 2020-bl-mc-insights-01_132x132

    Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

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  • 2018-bl-thumb-top-5-med-device-industry-trends-atypical tech-2

    Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

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  • 2018-bl-thumb-gxp-lifeline-regulatory-manager

    How to Make Pre-Sub Program Communication With the FDA More Transparent

    If you're getting close to submitting a medical device for market clearance through the FDA, you may want to read this month's Regulatory Manager Tip. The best type of communication for this process is to create even greater transparency by creating a venue for interaction with FDA staff for a "pre-sub" review of your device submission.

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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-manufacturing-excellence-03_132x132

    Building a Vendor Qualification Program for FDA-Regulated Industries

    A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.

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  • 2018-bl-thumb-tga-process-conformity-assess

    TGA Process for Conformity Assessment in Australia

    If you’re considering the Australian market for your medical device product and don’t have CE marking, the conformity assessment is an ever-increasing opportunity to enter the market. Furthermore, with the ever-changing landscape in Europe, many would suggest that Australia's Therapeutic Good Administration (TGA) is a well-established and understood pathway, whereas the European market is becoming somewhat more challenging and less understood.

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

    Top Medical Device Trends in Asia-Pacific and Around the World

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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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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