Medical Device

  • Hu-Friedy

    Hu-Friedy

    Read how MasterControl helped Hu-Friedy ensure compliance with FDA's 21 CFR Part 820 Quality System Regulation (QSR), and ISO 13485.

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  • Namsa

    Namsa

    NAMSA, a leading contract testing laboratory relies on MasterControl to meet rigorous FDA and ISO requirements.

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  • Megadyne

    Megadyne

    Megadyne Medical Products has a global customer base, which means the medical device organization must comply with the requirements of multiple regulatory agencies.

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  • Top 5 Clinical Trends in the Medical Device Industry in 2018

    Top 5 Clinical Trends in the Medical Device Industry in 2018

    This white paper provides the inside scoop on the five trends currently making the most waves in the clinical research area of the medical device sector.

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  • EU MDR: How to Prepare for the Upcoming Changes in Regulation

    EU MDR: How to Prepare for the Upcoming Changes in Regulation

    The Medical Devices Regulation and In Vitro Dianostic Regulation deadlines are fast approaching. Learn the requirements, timelines, and terminology you need to be prepared.

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  • Top Manufacturing Device History Record Trends in 2019

    Top Manufacturing Device History Record Trends in 2019

    Examine technology-heavy manufacturing trends that the medical device industry can expect in 2019 and beyond, particularly as they relate to device history records (DHRs).

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  • Top 5 Medical Device Industry Trends in 2019

    Top 5 Medical Device Industry Trends in 2019

    In this white paper, MasterControl asked four medical device experts to share their insights on trends and developments that are likely to affect the industry in 2019.

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  • Top Device History Record Pain Points

    Top Device History Record Pain Points

    Device history records (DHRs) are the most important artifacts generated in the course of medical device manufacturing, yet many manufacturers still rely on manual, paper-based DHR systems.

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  • The Evolution of Medical Device Clinical Trials: Their Background and a Look Toward the Future

    The Evolution of Medical Device Clinical Trials: Their Background and a Look Toward the Future

    Knowledge of regulatory requirements and the application of rigorous clinical investigation processes can help companies accelerate the time it takes to bring new devices to the market.

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  • Top 5 Medical Device Industry Trends in 2018

    Top 5 Medical Device Industry Trends in 2018

    Digital device technology continues to move at a fast pace, which means device manufacturers should keep a close watch on emerging trends and be ready to adapt to new ideas and methodologies.

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  • How to Address the Top 6 Pains in DHF Management

    How to Address the Top 6 Pains in DHF Management

    Noncompliance among medical device developers typically falls under two areas: design control and document management. These two critical elements intersect in one place: the design history file.

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  • Top 5 Trends in the Medical Device Industry in 2017

    Top 5 Trends in the Medical Device Industry in 2017

    In this eye-opening white paper, medical device experts Matt Lowe and Alex Butler offer their predictions for the top five industry trends that will likely have the most impact this year.

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  • ISO 13485 - Change? Do I Have To??

    ISO 13485 - Change? Do I Have To??

    Review the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system.

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  • How Medical Device Firms Can Thrive Despite Tax Uncertainty

    How Medical Device Firms Can Thrive Despite Tax Uncertainty

    The medical device landscape is changing, due in large part to the controversial U.S. excise tax that applies to American-made and imported medical devices.

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  • cGMP and ISO 13485 Integrated Quality Management System

    cGMP and ISO 13485 Integrated Quality Management System

    The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (QSR), also known as 21 CFR 820 or 'Current good manufacturing practice' (cGMP).

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  • Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

    Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

    Examine how obtaining ISO 13485 certification can open doors to untapped domestic and international business opportunities, and obtain recertification to the new revision.

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  • The Value of Studying and Utilizing FDA's QSIT Manual

    The Value of Studying and Utilizing FDA's QSIT Manual

    The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.

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  • Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?

    Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?

    When a company’s product development engineers and quality professionals fail to cooperate adequately, the company risks experiencing costly delays and inefficiencies.

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  • Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments

    Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments

    How an enterprise quality management system (EQMS) can help you avoid 483 observations during your next facility audit.

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  • Software Trends in the Medical Device Industry

    Software Trends in the Medical Device Industry

    This white paper summarizes the different categories of solutions available so as to make the selection process easier and maximize the benefit of software automation in the medical device industry.

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