Medical Device

  • 2020 Ultimate Guide to Connected Quality Data

    2020 Ultimate Guide to Connected Quality Data

    Visualizing a new data-centered quality paradigm. When the first Nokia and Motorola cell phones that were affordable and small enough to fit in your pocket hit the market...

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  • Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers

    Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers

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  • Cochlear Helps People Hear with the Help of MasterControl2:50

    Cochlear Helps People Hear with the Help of MasterControl

    Cochlear helps people hear and be heard by providing high-quality devices. They use MasterControl to ensure quality across the organization.

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  • 5 Top Medical Device Industry Trends to Plan for in 2020 - Trend Brief

    5 Top Medical Device Industry Trends to Plan for in 2020 - Trend Brief

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  • Top 5 Medical Device Industry Trends in 2019

    Top 5 Medical Device Industry Trends in 2019

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  • 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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  • 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 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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  • 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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  • 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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  • MasterControl eDHR™ Toolkit for Medical Device Firms

    MasterControl eDHR™ Toolkit for Medical Device Firms

    Address the challenges most medical device manufacturers experience during the device history record (DHR) process when they aren’t properly leveraging an electronic DHR (eDHR) system.

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