MedicalDevice.jpgMedical device companies are under increasing pressure to be ready for product commercialization from the 'get go' by being operationally efficient while being in compliance with global regulatory agencies. Successful commercialization requires effective Design Control, Document Control and Engineering Change processes for product development. Efficient management of operational processes, e.g. Corrective Action and Preventive Action (CAPA), Training Management, Non-Conforming Materials Reporting (NCMR), Equipment Calibration, Supplier Qualification, etc. is mandatory. Executives need effective process metrics and trends so that they can measure the operational effectiveness of their product's commercialization.

In order to develop leading products in the Medical Device industry, product development organizations must focus on innovation, not get bogged down with manual or ineffective automated processes. And, as in other industries, companies must also meet the challenge to utilize capital effectively. Focusing on core competencies and partnering for product design and product manufacturing with other companies can often enable more efficient and cost-effective design processes, but this environment also creates a strong need for collaboration both within the enterprise as well as throughout the supply chain.

Areas that are of serious concern to medical device companies during the product development process are:

  • DMR Change Tracking
  • Design Revision Tracking
  • Synchronization of Product Information (i.e. Product Requirements, Design Specifications, Assembly Procedures, Validation Protocols, etc.)
  • Real Time Collaboration between Design, Engineering & Manufacturing
  • Managing Standard Operating Procedures and Training
  • Managing the Product Life Cycle from Conception to Obsolescence


QuadRite's RitePro™ Product Lifecycle Management (PLM) solution provides a built-in, best practice based information model, business rules and use cases to address the above-mentioned concerns for Medical Device enterprises. RitePro is an out-of-the-box application that can be deployed within days, instead of months. As a fully web-native application with Internet browser as the only client, it minimizes the IT support need and enables ease of information access and sharing across the extended enterprise.

QuadRite's RitePro solution includes:

  • Product Structure and DMR Management
  • Document Management
  • Management of Standard Operating Procedures
  • Management of Design Control Process
  • Life Cycle Management
  • Change Management
  • Management of Operational Processes (CAPA, NCMR, Supplier Qualification, etc.)
  • Management of Device History Records
  • Viewer Management
  • Training Management
  • Executive Dashboards including Process Metrics, Trends and Exception Reports
  • Security and Access Management
  • Interface & Integration
  • 21 CFR Part 11 Compliance
  • Risk Management

Button-RequestDownload