License to Cure for Medical Device

Accelerate the delivery of innovative, safe & fully compliant medical devices

License for DHF Change

Concentrate on critical resources

Quality and time-to-market are competing priorities in the medical device industry and must be well managed through a careful process in order to reduce increasing regulatory and compliance risks.

Project and program management is particularly helpful for providing structure and focus throughout the various design phases. In addition, gaining early visibility of the product capabilities to the entire organization helps ensure regulatory and marketing teams support when preparing regulatory for FDA approval for commercialization and post-market surveillance activities. 

License for DHF Change provides advanced project management capabilities for medical device companies to institutionalize best practices in executing new product introduction projects. It helps coordinate project activities and deliverables to ensure completion of design control deliverables and automatically populates the resulting Design History File (DHF).  Project managers are provided with templates tasks and deliverable check lists to make sure that SOP (standard operating procedures) are fulfilled and included in the project. Advanced visual project tracking reports within the 3DEXPERIENCE® platform also help maximize management visibility and control to help improve time-to-market, avoid regulatory risk, and improve operational excellence.

Key Benefits

  • Save time and reduce compliance risks leveraging global product development strategy that links all parts of the organization together to provide full visibility of all product related information
  • Assign the appropriate amount of time and resources to each phase of the development cycle with real-time collaboration
  • End-to end consistency and complete DHF traceability
  • Immediate, real-time access to all product information for impact analysis
  • Organize and manage a company's product portfolio and execute development projects related to the planning and introduction of future products
  • Real-time access to the right product information for any investigation (e.g. complaint, change impact assessment)

By leveraging the 3DEXPERIENCE platform that combines engineering, quality, and regulatory compliance business processes, we have moved closer towards becoming the R&D and manufacturing center of choice for our customer.

Lim HN Olympus Technologies Singapore