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PLM for Medical Devices

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Our Product Lifecycle Management (PLM) for Medical Devices helps small- to medium-sized manufacturers overcome product complexity and the burdens of industry regulation. It’s an integrated, cloud-based product development system that integrates disciplines to drive optimal product functionality. Reusing, context capture, and collaboration helps improve visibility and traceability through digitalization while reducing costs and compliance risks. As demands change, PLM for Medical Devices is future-proofed to deliver safe, effective, and compliant products.

Our Product Lifecycle Management (PLM) for Medical Devices helps small- to medium-sized manufacturers overcome product complexity and the burdens of industry regulation. It’s an integrated, cloud-based product development system that integrates disciplines to drive optimal product functionality. Reusing, context capture, and collaboration helps improve visibility and traceability through digitalization while reducing costs and compliance risks. As demands change, PLM for Medical Devices is future-proofed to deliver safe, effective, and compliant products.

Medical devices in an operating room

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Medical devices in an operating room

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A modern surgical facility

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PLM strategy for Medical Devices

PLM for Medical Devices helps manufacturers develop devices efficiently and increase their competitive advantage in the face of market and regulatory pressures.

Comprehensive PLM software provides complete design control digitalization, integration to design and document authoring apps, and workflow-based change control and CAPA processes resulting in high-value, optimized devices.

Automate, standardize, and enhance your product development process. Manage product variations according to regional needs. Realize complete traceability from risks and requirements to V&V testing to DHF/DMR records and regulatory submissions. Maintain a digital system of record that’s web-accessible, secure, and compliant.

Integrated, multidisciplinary medical device design

Improve innovation, speed to market, and quality, enabled by:

  • Data-driven, automated processes
  • Document, design and change controls
  • Efficient cross-domain engineering collaboration
  • Integration with manufacturing & other QMS processes
  • Data-centric corrective and preventative actions (CAPA) medical device controls
A modern surgical facility

ソリューションの機能

Explore the key areas of this solution.

Artwork & Labeling

Our medical device artwork and labeling solutions provide all relevant product specifications within a single, unified, digital platform, helping companies minimize risk and maximize efficiency.

Bill of Materials Management

Manage costing for medical device manufacturing within the context of product change and configuration management. This context includes BOMs, materials, and process data, thus enabling change impact and accurate update analysis.

Change Control & CAPA

Workflows digitalize, globalize, harmonize and accelerate your capstone processes.

DHF, DMR, TF & Submissions

Template-driven, re-usable, configurable regulatory record and document collections.

Document Control

Integrated document authoring, via PLM embedded in your Office and Adobe apps.

Electrical CAD Data Management

Integrated 3D design system via PLM embedded in your ECAD apps.

Mechanical CAD Data Management

Integrated 3D design system, via PLM embedded in your MCAD apps.

PLMファウンデーション

SaaS PLM, for faster time to value and lower cost of ownership, or on-premise.

Product Requirements Engineering

Drive the product development process by generating reports, documentation, and dashboards to manage the requirements process. Create, view and edit requirements directly from familiar Microsoft Office applications.

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