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Essential Quality Package​

 

The ‘Essential Quality Package’ is suitable for early stage Medical Device Manufacturers including startups and new device groups in a larger and matured manufacturer that are still in design and development mode. The Essential package includes all the necessary components to develop and establish a quality system that can grow with the organization to the ‘Total Quality Package’ when the organization is ready. Essential Quality Package offers an out of the box system that makes a Medical Device Manufacturer ready with Continuous Quality and Compliance (CQC) from day one.

 

The following components make Essential Quality Package covering Quality Management System (QMS), Application Lifecyle Management (ALM) and Risk Management System (RMS):

  • Quality System

  • Documents

  • Design Control

  • Agile Development

  • Deployment & Production

  • Purchasing

  • Resource Management

  • Omnibus Integration Server

All of 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, Essential 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.