Medical Device Industry

The MasterControl Development Excellence solution digitizes and automates the management of design history files (DHF) and device master records (DMR) to help embed quality directly into early product development. It facilitates cross functional collaboration and document control to ensure that documents are easy to track, retrieve, revise, approve, and share departmentally to improve efficiency, accelerate time to market and ensure compliance.

The MasterControl Clinical Excellence solution digitizes all the documents, collaborations, sites, study information and tasks throughout the clinical lifecycle for multiple sites and CROs. MasterControl effectively manages all interactions to ensure site protocols and audit readiness.

The MasterControl Regulatory Excellence solution simplifies the management of documentation for submissions and dossiers, streamlines global registrations and harmonizes regulatory information with quality data. It simplifies and automates critical workflows associated with managing 510(k) registrations, technical documents and dossiers for global registration in multiple countries with a global checklist template designed to mirror regulatory pathways.

The MasterControl Quality Excellence solution accelerates enterprise quality management and removes the anxiety associated with regulatory inspections and audits to proactively improve quality, accelerate time-to-market and create a sustainable competitive advantage. MasterControl streamlines and automates GxP processes and facilitates effective document control, change control, training management, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes throughout the product lifecycle.

The MasterControl Supplier Excellence solution increases visibility while ensuring quality and compliance across the supplier ecosystem - from sourcing through production and post market. MasterControl streamlines supplier management to ensure quality and compliance requirements are consistently fulfilled throughout the supply chain along the product lifecycle. It integrates supplier quality management (SQM) and approved vendor lists (AVL) management while automating document control and change control processes like supplier corrective action requests (SCARs) and supplier approval status.

The MasterControl Manufacturing Excellence solution helps bridge the paper gap between quality management systems and manufacturing execution systems by automating the labor-intensive last mile of the manufacturing production process. It helps eliminate paper-based DHRs and manual review cycles by automating the building, execution and review of DHRs and product family variations that increase productivity, cycle times and release delays to drive immediate improvement and operational efficiency.

The MasterControl Postmarket Excellence solution allows device companies to effectively manage in-market complaints and close the quality management loop by automating actionable and intelligent postmarket surveillance as a catalyst for product improvement.