Quality and Compliance

Device Master Record Manager ()

Device Master Record Manager

Device Master Record Manager saves companies time and effort by eliminating redundant data entry and validation of medical device procedures and specifications with a single, centralized, secure, digital repository that helps ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements.

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Description

Increasing business, product and process complexities affect operating margins and are driving companies to find business solutions which foster innovation and improve efficiencies. In the Life Sciences industry, the complexity and rate at which new products need to be developed has already out-paced the rate at which many companies can produce them. Furthermore, the rate at which companies need to develop product content is expected to continue to grow faster than the current rate of productivity improvements.

Device Master Record (DMR) is the term used in the Quality System (QS) regulation for all of the routine documentation required to manufacture devices that will consistently meet company requirements and is built up throughout the life cycle of the product. Experienced medical device development and manufacturing teams recognize the significant scope of today’s document control requirements and the severe limitations of spreadsheets and paper files to bring innovative devices to market. Engineering, operations design partners, and quality team members must have secure access to a single, unified version of product data to manufacture a compliant product.

Device Master Record Manager works seamlessly with Manufacturing BOM Manager to establish a DMR for each manufacturing location and address the following business challenges:

  • Automate and efficiently manage the compilation of DMR records
  • Save time and eliminate errors caused by existing information silos and redundant systems which manage the Device Master Record
  • Enable global product teams to efficiently collaborate, approve and implement device designs, specifications and procedural changes through a common, automated change process

Key features & benefits

  • Consolidate part design and related technical document content from multiple engineering tools by providing a single definition of the EBOM

  • Increase product innovation through improved communication and collaboration with global development teams leveraging 3D visualization and electronic communication

  • Decrease time from design release to manufacturing readiness by implementing a solution that enables concurrent design

  • Reduce manufacturing costs by identifying and resolving manufacturability issues early in the development process

  • Perform comprehensive evaluation and selection of components while defining the EBOM

  • Consolidated management of all engineering and manufacturing BOM data and processes in one enterprise solution