Medical Devices & Equipment

Medical Devices & Equipment

Industries such as Medical devices rely on robust process and documentation management to meet the needs of regulatory agencies. Managing all of this critical product information is not only necessary, it’s required.  Fusion Lifecycle, a multi-tenant Cloud-based PLM system, is built upon a highly configurable interface that allows the solution to easily adapt to existing processes and environments, while also extending beyond traditional PLM functions.

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Addressing Key Industry Challenges

Maintain Device Master Record Control

Capture, track, and control the Device Master Record (DMR) across the entire organization in a central repository. Include related information such as design documents, test and validation procedures, and manufacturing instructions.

Manage Document Control and History

Distribute controlled documents, enforce standards, and manage change of your compliance documents. Create linkages between your DMR controlled documents and other process documentation such as quality and training records.

Safeguard Audits with Traceability

Validate, track and control each stage of your product development with related tasks and deliverables. Automatically create Design History Files (DHF) to provide a record of processes with a detailed change history and electronic signatures to comply with regulatory requirements.

Track Training Records

Automate documentation and management of employee training records in real-time. Directly link training procedures and requirements to relevant documentation. Generate training notification and maintain audit trails.

Establish Secure Collaboration

Provide controlled access to internal teams, customers and suppliers to participate in critical product development processes with real-time notifications on design reviews and product changes.

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