Postmarket

  • Complaint Handling as an Integral Part of FDA and ISO Compliance

    Complaint Handling as an Integral Part of FDA and ISO Compliance

    Effective complaint handling is not just a good business practice, but a critical compliance requirement in FDA and ISO environments.

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  • Guidelines For The European Medical Device Vigilance System

    Guidelines For The European Medical Device Vigilance System

    "How-to" information for medical device companies complying with regulations standardized by the MDDs (Medical Device Directives). Access the MEDDEV-5 when developing quality and compliance processes.

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  • MasterControl Field-Based Solutions (FBS) Customer Complaint™

    MasterControl Field-Based Solutions (FBS) Customer Complaint™

    MasterControl Field-Based Solutions (FBS) Customer Complaint™ is a configurable form-based process solution for documenting complaint information easily and efficiently.

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  • MasterControl eMDR™

    MasterControl eMDR™

    The FDA requires medical device manufacturers to report any adverse events to the agency.

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  • MasterControl Customer Complaints™

    MasterControl Customer Complaints™

    Address the key complaints-handling challenges of different sources, disconnected processes and an inefficient complaint process by automating and integrating your complaint handling.

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  • Px Solution Overview

    Px Solution Overview

    The MasterControl Postmarket Excellence™ solution streamlines the capture and documentation of postmarket feedback from customer complaints and surveys to manage risk and ensure compliance.

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  • MasterControl Postmarket Excellence™ Solution Overview

    MasterControl Postmarket Excellence™ Solution Overview

    The MasterControl Postmarket Excellence™ solution is the next generation of integrated surveillance, customer feedback and quality management processes.

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  • Fagron Uses MasterControl's Quality Management for their Personalized Medicine4:06

    Fagron Uses MasterControl's Quality Management for their Personalized Medicine

    When it comes to personalized medicine, quality is paramount. Fagron uses MasterControl for their Quality Management Systems (QMS Software).

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  • Best Practices in Post Market Intelligence27:30

    Best Practices in Post Market Intelligence

    Medical device companies are required to conduct post-market surveillance (PMS) on their devices to maintain high product quality and safety.

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