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 (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. Device Master Record Manager enables companies to automate and effectively manage the compilation of records containing procedures and specifications for finished device to help ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements into a single, centralized, secure repository. Device Master Record Manager eliminates silos and redundant systems to manage the Device Master Record and leverages a common change process to manage device designs, specifications and procedural changes.
Improved communication and collaboration with global development teams comprised of internal and external resources greatly improves the compliancy, accuracy and efficiency of product record maintenance by saving time, effort and ensuring accuracy for part consumption and reconciliation. Companies can accelerate their new product introductions, improve collaboration with outsourced partners and suppliers and achieve compliance with confidence.