• 2018-bl-thumb-whats-hiding-in-your-labeling-artwork

    What's Hiding in Your Labeling Artwork?

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

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    Advancing the Case for Quality in Medical Device Manufacturing

    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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  • 2018-bl-thumb-braveheart-team-emphasizes-quality-first-approach

    BraveHeart Team Emphasizes Quality-First Approach

    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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  • 2018-bl-thumb-fmea-without-tears

    FMEA Without Tears: A Prescription to Reduce Pain and Confusion

    Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.

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  • 2019-bl-thumb-braveheart-update-tl

    Airplane Preflight Check Exemplifies Quality in Med Device Design

    Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.

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  • 2018-bl-thumb-shifting-reimbursement-landscape-australia

    Getting Paid: A Shifting Medical Device Reimbursement Landscape in 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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    Top 5 Nutraceutical Trends in 2018 - Exploring Different Delivery Methods

    The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.

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  • 2018-bl-thumb-braveheart-patch

    Med Device Company Takes Flight With Life-Changing Innovation

    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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    Expert Tips on Enhancing CAPA Through Innovation

    This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.

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  • 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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  • stocked-warehouse-with-orange-shelves-132

    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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    The Evolution of Medical Device Clinical Trials, Part 1

    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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  • 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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  • 2018-bl-thumb-leveraging-value-quality-business

    Leveraging the Value of Quality in Your Business Through ISO

    Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.

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  • business-icons-digital-touchboard-132

    Ugly Babies, Silent Enemies and Other Short Stories from a Continuous Improvement Conference

    Continuous improvement professionals, managers, and executives from the U.S. and Canada presented at the recent Canadian Lean Conference in June 2018, which drew about 1,000 business leaders to Winnipeg. Presenters shared lessons and results from lean transformation efforts as well as some personal journeys. Here’s a digest of some of the stories I heard.

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  • laboratory-bio-data-analyst-132

    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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  • 2018-bl-thumb-top-5-nutraceuticals-functional-food

    Top 5 Nutraceutical Trends in 2018 – Functional Foods

    The dietary supplement and functional foods markets overlap to a certain extent. Rather than trying to resist this, nutraceutical companies can get the best of both worlds by expanding their offerings to include functional snacks and beverages.

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  • 2020-bl-compliance_132x132

    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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