Successful commercialization of medical devices require effective Design Control, DMR Management, Document Control and Change processes for product development. Efficient management of quality processes, e.g. Corrective Action and Preventive Action (CAPA), Training Management, Complaint Management, Non-Conforming Materials Reporting (NCMR), Supplier Qualification, etc. are essential for regulatory compliance and operations efficiency.

Executives need effective process metrics and trends so that they can measure and continually improve the operational effectiveness of their product’s commercialization.

Medical 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.

In order to develop leading products in the Medical Device industry, companies must focus on innovation, and effective and efficient processes. As in other industries, companies must also meet the challenge of efficient use of capital.

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 and Change Tracking
  • Design History and Revision Tracking
  • Synchronization of Product Information (e.g. Product Requirements, Design Specifications, Assembly Procedures, Validation Protocols, etc.)
  • Efficient Real Collaboration between Design, Engineering, Manufacturing & Quality Departments
  • 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 that is offered both as a cloud or in-house solution, 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 Quality System Processes (CAPA, NCMR, Supplier Qualification, etc.)
  • Management of Device History Records
  • Requirements Management and Traceability
  • Training Management
  • Executive Dashboards including Process Metrics, Trends and Exception Reports
  • Security and Access Management
  • Interface & Integration with other systems
  • 21 CFR Part 11 Compliance