Siemens PLM for Medical Devices Now Available

Siemens PLM for Medical Devices from Siemens Digital Industries Software is an instant-on, cloud-based product lifecycle management (PLM) system that helps maintain data integrity and provides the infrastructure to ensure compliance, the company reports.

Accelerate Innovation via Digitalization

PLM for Medical Devices incorporates three key areas: design data management, product line management and quality process management.

This product supports end-to-end business processes with a preconfigured offering. Design teams can collaborate and share work in progress (WIP) to define and complete development processes. It includes built-in best practices such as Design History File, risk analysis and requirements, corrective and preventive actions and process management. Connection to enterprise resource planning and manufacturing systems enables compliance with various regional regulations.

Features include:

• Built-in risk analysis set to ISO 149 standards
• Multi-bill of materials management for integrity of interactions with suppliers and production
• Integrated, multi-CAD design environment
• Complete traceability of design history file-device master record/submissions for simplified regulatory interactions
• Live reporting on medical device verification and validation testing
• Object-based document management for ease of design transfer
• Revision and version control of regulatory controlled documents

Sources: Press materials received from the company and additional information gleaned from the company’s website.