Development

  • 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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  • Managing Change Control to Comply with FDA and EU Regulations

    Managing Change Control to Comply with FDA and EU Regulations

    Uncontrolled changes to a pharmaceutical or medical device product have the potential to affect public health and safety.

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  • Reducing the Documentation Burden in FDA Design Control

    Reducing the Documentation Burden in FDA Design Control

    This white paper shows how medical device developers can better manage all the documentation required for a product launch.

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  • Automating Electronic Engineering Change

    Automating Electronic Engineering Change

    Whether expected or unexpected, minor or complex, change is a constant in any manufacturing environment.

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  • Change Control - Continuous Quality Improvement in FDA and ISO Environments

    Change Control - Continuous Quality Improvement in FDA and ISO Environments

    In highly regulated environments, changes to equipment, materials, facilities, design, processes, packaging/labeling, computer systems, documentation, etc. pose a potential risk.

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  • MasterControl Field-Based Solutions (FBS) Management of Change (MOC)™

    MasterControl Field-Based Solutions (FBS) Management of Change (MOC)™

    MasterControl Field-Based Solutions (FBS) Management of Change (MOC)™ offers a new kind of form-based process solution that simplifies the management of change – regardless of size, source or impact.

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  • Design Control Toolkit

    Design Control Toolkit

    The Design Control Templates offering is a suite of documents that allows the user to comprehensively establish an all-inclusive Product Development Program (PDP).

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  • MasterControl Change Control™

    MasterControl Change Control™

    MasterControl Change Control™ automates every step of the change control process and keeps your quality system in a state of constant audit- and inspection-readiness.

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  • MasterControl Development Excellence™ Solution Overview

    MasterControl Development Excellence™ Solution Overview

    MasterControl has been providing software solutions to highly regulated industries for over 25 years.

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