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GxP Lifeline

Showing items tagged as Risk Management

  • 2020-bl-matt-brawner-qa_132x132

    Risk Management: A Primer for Lean Quality Assurance

    Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.

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  • 2021-bl-embed-risk-based-thinking_132x132

    Embedding Risk-Based Thinking Into Quality Efforts with an Integrated Risk Management Software

    Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Risk management guidelines are spelled out in international regulations and standards, but true risk management goes deeper and is applied throughout the product’s life cycle.

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  • 2021-bl-measuring-risk-management_132x132

    How to Measure Risk Management Outcomes

    The task of measuring the benefits risk management brings to an organization is a challenging one. To overcome this challenge, the measurement of risk management performance needs to consider a wide range of factors.

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  • 2020-bl-brandwood_132x132

    ISO 14971: 2019 and ISO TR 24971: 2019 Medical Device Risk Management Standards

    This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.

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  • 2019-bl-thumb-med-device-trends-2

    2019 Med Device Trends to Watch For: Human Factors Engineering

    To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts

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    Despite a Focus on Risk Management, Why Do Unthinkable Things Continue to Happen?

    Accidents and errors, in life and in manufacturing more specifically, continue to happen despite heightened levels of risk management and international standards. Find out why time, frequency and probability can’t be factored in to calculate likelihood and learn the key to determining actual risk.

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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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  • 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-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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  • 2018-bl-thumb-british-mhra

    UK's MHRA Issues Final Guidance on GxP Data Integrity

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • 2018-bl-thumb-compliant-analysis

    Complaint Analysis: Don’t Forget the Work You’ve Already Done

    This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.

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  • mc-logo-220x25

    Establishing a Master Harms List: Streamlining Risk Management

    Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety.

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