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High consumer expectations for better healthcare and advances in technology that improve quality of life are creating favorable market conditions for medical device companies. But increasing regulatory scrutiny is putting medical device manufacturers under the gun on total quality and safety. License to Cure for Medical Device solution allows companies to eliminate scattered processes and data and to “embed” regulations as an asset, optimizing quality and compliance and reducing cost and time to market.

This end-to-end solution supports all aspects of a medical device company’s quality system and regulatory compliance ISO-regulated design controls.

In addition, in an effort to address event reporting, reduce recalls and improve patient safety, manufacturers needs flexible solutions that manage the packaging and UDI code print and all quality issues including product complaints, non-conformance reporting (NCRs), audits and CAPAs, through a single, global, online system.

Key Benefits:

  • Conquering complexity focusing on regulatory compliance
  • Embedding regulatory compliance as an asset
  • Balancing innovation in product development with Quality & Safety

Accelerate the production of your visual assets

The medical device industry is poised for a sustained period of extreme growth. High consumer expectations for better healthcare and advances in technology that improve quality of life are creating favorable market conditions. Yet rising costs and compliance concerns are forcing medical device companies to proceed with caution – balancing the competitive drive for product innovation and quality compliance with safety and traceability requested by regulatory agencies.

Our License for Requirement Change solution enables you to create a virtual environment for gathering customer needs and creating requirements that can be managed in a fully-visible, traceable and collaborative environment to ensure product safety and automate regulatory overhead.

The 3DEXPERIENCE Platform enables product managers to define tests to ensure that requirements meet expected product quality and customer needs and evaluate the impact of proposed engineering changes across multiple products and features. The Platform enables an immediate assessment of Change impact and audit traceability gaps in real time.

Key Benefits:

  • Realtime collaboration on same up to date version
  • End to end consistency from design intent to submitted to manufactured
  • Early design issues detection
  • Seamless Regulatory Compliance, avoid risk of errors, save time
  • Accelerated Change Impact Assessment
  • Immediate view of all sub-requirements, product parts, tests impacted

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)

Give a new dimension to your storytelling!

Companies that fail to incorporate an end-to-end, quality process system throughout the lifecycle of the product increase the threat of compliance risk, cost overruns, and time delays. Many compliance risks are due to traceability gaps coming from legacy paper-based systems, siloed electronic documents, or different versions of software used by the different teams. Engineering and manufacturing collaboration is key to developing high quality products and must work closely together in the early stages of the project.

License for DMR Change helps to improve cross functional design and manufacturing collaboration by sharing views of a common engineering and planning activities. It helps to quickly approve complex changes and evaluate improvements in various change processes.

The 3DEXPERIENCE® platform enables engineering and manufacturing managers to make more informed design decisions reducing data entry time and manufacturing errors and finding easily updated BOM information.

Key Benefits :

  • Early collaboration between engineering and manufacturing in initial product design speed up change process
  • Multidiscipline team collaboration on the latest product information
  • Improved regulatory compliance – avoid risk of errors, less time
  • Robust CAPA support and support for all impacted product lines
  • Product Structure IP Capitalization & Reuse

Medical Device companies operate more globally to deliver their product more efficiently and at the best quality level. Conforming to regional environmental compliance directives such as RoHS, REACH, Packaging, and WEEE is now mandatory, but connecting the whole ecosystem is an even bigger challenge.

License for Green solution allows medical device companies to consolidate all supplier related information including raw materials use. Product materials compliance can be assessed at any phase of the development and delivery process through integration with Engineering BOM Management, or, with third party PLM and ERP system integration.

The 3DEXPERIENCE® Platform facilitates the data collection process by providing an on-line suppliers  dashboard to view material declaration requests, download parts in an industry-standard data collection format and upload completed material declarations. In addition, it helps enhance supplier reporting responsiveness and provides management full visibility of all product compliance data.

Key Benefits :

  • Keep pace with ever changing regulations to ensure product compliance, market access, and protect brand image
  • Successfully integrate the supply chain in a standardized and well-managed compliance declaration collection process
  • Ensure data quality and consistency using industry standard tools and verifiable data review processes
  • Rapidly assess the compliance impact of new regulations to your supply chain and customers
  • Maximize the reuse of compliant components by providing Design Engineers with full visibility to compliance data
  • Gain approval for market entry by ensuring on-time, high quality, and accurate compliance certification

Conquering Complexity

The costs of achieving and maintaining compliant products are high, but the costs of non-compliance are even higher. Non-compliant products can lead to legal actions, lost customers, fines, lost revenue and in the worst case, exclusion from key regional markets. Having access to non-conformance management capabilities can automate the control and disposition process by identifying issues and tracking the review, monitoring and reporting of follow-up actions.

License for Quality solution manages complaints and non-conformance reports (NCRs) within an organization in an effective, consolidated, global approach.  It provides a best practice process for managing customer complaints and regulatory reporting.

Optimize document management and compliance

Strict global regulatory oversight intensifies the pressure as companies struggle to get their products to market while fully meeting regulatory requirements. Failures not only result in product delays, but often erode a company’s public image affecting market share and profits. Finding ways to increase revenues, while maintaining compliance and high levels of product safety is essential to maintaining a competitive edge. Compliance is a state, not an event.

License for Document Control optimizes document management in a single, flexible electronic change control process that enables enterprise-wide collaboration to improve operational efficiency.  The structured library helps to manage the whole documents for the quality management system and enforces compliance for creating, managing and storing files in accordance with global regulatory bodies.  It provides a configurable and an easy-to-use solution that helps companies automate and effectively manage document control processes to help ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements.

The 3DEXPERIENCE® Platform provides further support by providing central access to the entire document lifecycle from creation through obsolescence.

Key Benefits : 

  • Lower costs and streamline operations with a central document repository
  • Personalized document control workflow, document lists, implementation, and templates.
  • Time saving creations with all reusable information, ability to incorporate further documents as required
  • Complete training traceability management, Track progress and status information per document.
  • Realtime collaboration on SOPs update
  • End to end consistency
  • Fully Auditable Change Control
  • Reduce errors and cycle times with automated revision management
  • Seamless Regulatory Compliance for the end to end product activities

Optimize document management and compliance

Gaining the right product approvals and certificates for major markets is fundamental to both succeed and to ensure safety and effectiveness of every medical device. Properly defined and prepared submission reports help assure that the submission contains the appropriate defined information requested by the various regulatory bodies for the specific product classification. For example, the collection of products and key UDI attributes from a company’s systems can be automatically bulked to refine and reuse data for UDI submission and approvals.

License for Regulatory solution breaks the silo barriers within a company to create a more unified approach to taking a product to market, therefore significantly decreasing time to market. It allows companies to eliminate scattered processes and data and to “embed” regulations as an asset, optimizing and controlling the management of highly-regulated business processes for worldwide submissions and approvals.

Key Benefits :

  • Realtime collaboration
  • End to end consistency
  • Seamless dossier completeness
  • Time to market authorization delay reduction
  • Timely and traced regulatory answers
  • Full consistency between submission and actual product design
  • Submission effort reduced thanks to IP direct reuse
  • Actual product data reused for DI submission

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