Product Lifecycle Management (PLM) for Medical Devices is a pre-configured SaaS PLM solution that integrates disciplines to help medical device businesses improve product quality and regulatory compliance across their product lifecycle.
The demand for ever-more efficient, accessible and secure medical devices makes the design phase crucial for product development. Inventing or improving products is a multi-disciplinary, time-consuming process that needs precise coordination to ensure robust prototypes and timely launches. Obviously, a market launch with an inadequate design can lead to a safety recall or commercial failure.
of executives make design deadlines. (Lifecycle Insights)
of companies support digital transformation. (Lifecycle Insights)
of companies report increase in development complexity. (Lifecycle Insights)
How can pre-configured PLM SaaS solution, PLM for Medical Devices, help you tackle product development complexity?
This solution provides complete design control digitalization, integration to design and document authoring apps, labeling and UDI management, and workflow-based change control and CAPA processes for high-value, optimized devices.
Product Lifecycle Management (PLM) for Medical Devices is a pre-configured solution that helps you develop medical devices more efficiently while improving your quality and compliance.
Manage your design data, product lines and quality processes with SaaS PLM for Medical Devices.
Automate, standardize and enhance medical device product development processes. Manage product variations according to regional needs and realize complete traceability.
Explore our solutions to get started or visit Teamcenter X.
Try our Teamcenter X industry solution PLM for Medical Devices today and discover the power of software-as-a-service PLM. Explore the most common use cases such as traceability of DHF/DMR and submissions for simplified regulatory interactions, managing change, trace risk with hazard analysis into requirements and design, CAPA and integrated labeling and UDI throughout the lifecycle.
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Teamcenter received the highest possible scores in more criteria than any other evaluated vendor in The Forrester Wave™: Product Lifecycle Management for Discrete Manufacturers, Q1 2023 report.
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Start your PLM for medical devices journey with ease. Our support and service offerings will guide you along the way.
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With medical devices becoming increasingly complex and regulatory oversight tightening, it’s difficult for manufacturers to deliver products effectively and maintain a competitive advantage. But there are ways to improve innovation, speed to market and data quality while continuing to be compliant. PLM is a core system of record the medical device manufacturers need to achieve speed to market, risk reduction and enhanced collaboration. This includes change control, audit readiness and business process automation.
Our Product Lifecycle Management (PLM) for Medical Devices is an integrated end-to-end product development system that tackles complexity and regulation through re-use, context capture and collaboration. Manufacturers improve visibility and traceability while reducing costs and compliance risks to produce competitively differentiated premium-value devices.
PLM for Medical Devices is built with medical device companies in mind to support regulated work flows and compliance readiness. Examples include Part 11 compliance support, software validation packages, and engineering, quality, and regulatory solutions designed to work together in one system. All aspects of design control including supporting the design history file and preparation of regulatory submissions and coordination with manufacturing during design transfer.
The best medical device quality is achieved through design assurance, not downstream in manufacturing or post market surveillance. Manufacturers can gain significantly greater returns in quality by investing in their design control processes and systems. PLM for Medical Devices removes much of the fallibility of manual collaboration and enables design and quality teams to focus where their attention belongs – on the safety and efficacy of the product.
A well-built PLM enables teams to innovate more effectively through re-use and contextual learning from their device(s) data. Context requires traceability through knowledge transfer between teams and over time. Building in context is essential to maintain good clinical outcomes. Additionally, increasing speed of collaboration can enable more design cycles and opportunities to improve the design output.
On-demand webinar | Accelerating innovation in manufacturing with SaaS PLM for medical devices
On-demand webinar | The challenge of labeling & UDI for medical devices