Teamcenter 8 includes exciting new features for medical device manufacturers, further extending Teamcenter’s productivity advantage. Improvements for failure modes and effects analysis risk management, digital device master record (DMR) and design history file (DHF) documentation, external asset management, supply chain integration, and electronics design collaboration and software design management headline the new features.

Accelerated Product Design and Regulatory Records Management

• Enhanced Digital DMR – Organize DMR documents in folders based on document category, and easily configure the required set of documents in the “DMR Checker”.
• Enhanced Digital DHF – Classify documents and organize them in design control folders aligned with quality system regulations for GMP.
• ECAD Process and Data Management – Support for major ECAD and PCB layout applications. Embedded ECAD visualization including schematic logic diagrams; ECAD component library management supporting standard classification hierarchy; and design for manufacture/assembly support.
• Supply Chain Collaboration – Standards-based bill of materials (BOM) information exchange supporting PDX and Excel. Enhanced preferred vendor management and vendor part management including compliance information.
• Software Design Management – Manage software design components (source code, binaries, libraries, build files, test, specifications, documentation, etc.) as building blocks for re-use in the design of a larger software system.

Integrated Product Planning

• Requirements Management – Extend end-to-end requirements traceability with the ability to link the voice of the customer to the portfolio plan, project schedules, design and test data, and advanced baseline management.
• FMEA-Based Risk Management – Improve risk management with the ability to digitally identify product functions and link those functions to potential failure modes and effects.
• Portfolio Management – Improve management of portfolio changes by linking them directly to program execution.
• Program Execution – Enhanced support for globally distributed program/project management, project template management and phase gate deliverable management.
• Community Collaboration – Advanced idea and visual issues management.
• Strategic Sourcing – Enhanced support for Request for Information, Proposal or Quotation (RFx) management, spend management and reporting.
• Service and Asset Management – Management and traceability for as-built and as-maintained structures, including full asset visualization. Role-based access to service and asset management functions, and support for service events and service life history.
• Environmental Compliance – Analyze and track compliance at the substance, material, part, and product level against the RoHS, WEEE and REACH regulations.
• Authorized Data Access – Restrict information and audit access based on the terms and conditions specified by authorizing documents including export licenses, technical assistance agreements, non-disclosure agreements and supplier contracts.

All of this adds to our pre-existing CAPA, FDA Compliance (including Part 820), non-conformance management and quality systems capabilities.