PLM for Medical Device Manufacturers

Closed-Loop Quality for Medical Device Innovators

Regulatory approvals and faster compliance cycles with less effort

A PLM-enabled digital thread creates a consolidated “closed-loop” lifecycle system by combining regulators, manufacturers, and connected product-related data (Internet of Medical Things), resulting in end-to-end traceability.

With a fully integrated digital thread, medical device companies can avoid delays due to audits. Legacy systems and file cabinets that contain partial information can be retired. Instead, stakeholders are fully connected to the current state of the product throughout the entire lifecycle, streamlining change management and regulatory submissions.

Windchill, the industry-leading PLM software from PTC, provides the foundation and continuity of product and quality information across the digital thread, whether delivered on-premises or SaaS. With a validation-ready cloud, medical device companies and their design/manufacturing partners can take advantage of enterprise and multi-enterprise secure collaboration. Plus, Windchill’s out-of-the-box pre-configured ISO 13485 processes can be implemented quickly.

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Case studies

See how PTC’s medical device customers are benefiting from a PLM-enabled digital thread with Windchill Product Quality.

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Smith and Nephew

Smith and Nephew is improving digital traceability throughout its products/ lifecycles across all business units by using PTC’s life sciences PLM solutions to establish a product-driven digital thread.

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Bose

Bose accelerated their time to market, QMS validation, and FDA clearance by using PTC’s life sciences PLM solutions to achieve document control, co-managed BOMs, and full track change management.

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CONMED

CONMED improved the safety and efficacy of their products by using PTC’s life sciences PLM solutions to unify their core regulated processes, quality management, and product development into a single system.

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Medical device resources

Analyst Report: Uniting Quality and PLM in Medical Device

Read this Knowledge Brief from Aberdeen to explore how the digital thread can be leveraged for improving quality management.

Read this Knowledge Brief from Aberdeen to explore how the digital thread can be leveraged for improving quality management.

E-book: PLM as the Foundation for Digital Transformation in Medical Device

A PTC e-book for medical device stakeholders wrestling with quality, risk and an evolving regulatory environment.

A PTC e-book for medical device stakeholders wrestling with quality, risk and an evolving regulatory environment.

Buyers Guide: Choosing the Right PLM for the Medical Device Digital Thread

Take advantage of expert guidance on what requirements to consider when looking to digitally transform.

Take advantage of expert guidance on what requirements to consider when looking to digitally transform.

CIMdata’s Closed-Loop Quality Tool

Get industry-proven, personalized recommendations on capabilities that will help you meet your quality management initiatives.

Get industry-proven, personalized recommendations on capabilities that will help you meet your quality management initiatives.

Windchill Risk and Reliability Free Trial

Try out our fully integrated software suite, considered the industry’s most powerful reliability analysis toolkit.

Try out our fully integrated software suite, considered the industry’s most powerful reliability analysis toolkit.