ISO 13485 Quality Management Overview

ISO 13485 Quality Management is a specialized compliance software designed for organizations in the medical device sector. This platform facilitates the implementation and maintenance of a robust Quality Management System (QMS) that aligns with international standards. With features such as document control, audit management, and corrective action tracking, the software helps companies ensure compliance with regulatory requirements while enhancing product quality and safety. Users can easily manage quality records, monitor processes, and conduct risk assessments, streamlining the path to certification. The built-in reporting tools provide insights into performance metrics and compliance status, aiding continuous improvement initiatives. ISO 13485 Quality Management promotes a culture of quality within organizations, enabling them to meet customer expectations and regulatory demands efficiently. By adopting this software, businesses can not only achieve compliance but also enhance their operational efficiency and market competitiveness.

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Contact Details

  • Vendor Name AQA
  • Founded 1992
  • Location United States

Support

    NA


Training

  • Webinar Webinar
  • Documentation Documentation

Licensing & Deployment

  • Proprietary Proprietary
  • Cloud Hosted Cloud Hosted
  • Web-Based Web-Based

Typical Customers

  • Self-Employed Self-Employed
  • Small-Business Small-Business
  • Midsize-Business Midsize-Business

Languages Supported

English


Industries

Health, Hospital & Health Care, Information Technology & Services, Medical Practice

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ISO 13485 Quality Management Features

  • Arrow Icon HIPAA Compliant
  • Arrow Icon Compliance Tracking
  • Arrow Icon Risk Assessment
  • Arrow Icon Environmental Compliance
  • Arrow Icon Policy Management
  • Arrow Icon Alerts/Escalation
  • Arrow Icon ISO Compliance
  • Arrow Icon Incident Management
  • Arrow Icon Risk Management
  • Arrow Icon OSHA Compliance
  • Arrow Icon Document Management
  • Arrow Icon Task Management
  • Arrow Icon Surveys & Feedback
  • Arrow Icon Training Management
  • Arrow Icon Compliance Management
  • Arrow Icon FDA Compliance
  • Arrow Icon Audit Management
  • Arrow Icon Audit Trail
  • Arrow Icon Controls Audit
  • Arrow Icon Access Controls/Permissions

ISO 13485 Quality Management Pricing

Pricing Type

  • Pricing Type Per User

Preferred Currency

  • USD ($) USD ($)

Free Trial

  • Free Trial Available

Free Version

  • NA

Payment Frequency

  • One-Time Payment One-Time Payment

Plans & Packages

Basic

$1460 Per User

ISO 13485 Quality Management FAQs

ISO 13485 Quality Management is a specialized compliance software designed for organizations in the medical device sector. This platform facilitates the implementation and maintenance of a robust Quality Management System (QMS) that aligns with international standards. With features such as document control, audit management, and corrective action tracking, the software helps companies ensure compliance with regulatory requirements while enhancing product quality and safety. Users can easily manage quality records, monitor processes, and conduct risk assessments, streamlining the path to certification. The built-in reporting tools provide insights into performance metrics and compliance status, aiding continuous improvement initiatives. ISO 13485 Quality Management promotes a culture of quality within organizations, enabling them to meet customer expectations and regulatory demands efficiently. By adopting this software, businesses can not only achieve compliance but also enhance their operational efficiency and market competitiveness.

  • No, ISO 13485 Quality Management does not offer a free version.

  • Yes, ISO 13485 Quality Management offers a free trial.

  • No, Credit Card details are not required for the ISO 13485 Quality Management trial.

  • ISO 13485 Quality Management offers the following pricing plans & packages:

    Basic

    $1460 Per User

  • ISO 13485 Quality Management supports the following payment frequencies:

    • One-Time Payment

  • No, ISO 13485 Quality Management does not offer an API.

  • ISO 13485 Quality Management offers training with the following options:
    • Webinar , Documentation

  • ISO 13485 Quality Management supports the following languages:
    • English

  • Following are the typical users of the ISO 13485 Quality Management:
    • Self-Employed , Small-Business , Midsize-Business

  • ISO 13485 Quality Management supports the following deployment:
    • Cloud Hosted

  • ISO 13485 Quality Management supports the following devices and operating systems:
    • Web-Based