Total Quality Package

 

The ‘Total Quality Package’ is suitable for any Medical Device Manufacturers that needs a complete implementation of FDA 21 CFR Part 820 and ISO 13485 quality standard, typically for a post market stage. The Total Quality Package includes all the necessary components covering the FDA regulation and the ISO standard and offers an out of the box system that makes a Medical Device Manufacturer ready with Continuous Quality and Compliance (CQC) from day one. For pre-market stages the Medical Device Manufacturers can use Essential Quality Package instead.

The following components make Total Quality Package covering Quality Management System (QMS), Application Lifecyle Management (ALM) and Risk Management System (RMS) covering end to end ISO 13485 (Quality Management), ISO 14971 (Risk Management), IEC 62304 (Software life cycle processes):

  • Quality System

  • Documents

  • Design Control

  • Agile Development

  • Deployment & Production

  • Purchasing

  • Resource Management

  • Improvements

  • Services

  • Audits

  • CAPA

  • Change Management

  • Omnibus Integration Server

 

All these components are integrated with each other for a seamless experience. In addition, Omnibus Integration Server is included for organizations that are using various software development and IT tools and would like to integrate with MediDev. The list of integration adapters shows industry’s largest integrated tools ecosystem.

 

For the software development management, Total Quality Package includes the industry’s most popular Agile development that has been configured as per TIR45. However, if an organization decides to use any other development methodology like waterfall, V-model, stage gate or some proprietary one, MediDev allows a drag and drop configuration to create a development process matching the exact one an organization follows.

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