PLM Teamcenter X: cloud solutions for medical devices
We are privileged to rebroadcast the fourth episode in the Machine Builders podcast series, focusing on how Teamcenter X provides the benefits of cloud solutions for medical devices: design, data management, product line management, and quality process management.
Joining us are engineering experts Alexandre Berthod, Global Marketing Manager at Siemens Digital Industries Software, speaking with Ryan Bauer, Director of Medical Device & Pharmaceutical Solutions at Siemens, discussing the challenges of developing innovative medical devices and PLM cloud solutions benefits built on the Teamcenter platform.
Solutions in the cloud
PLM for medical devices builds on the Siemens Teamcenter platform for enterprise-grade product lifecycle management. It is preconfigured to support core product development, quality, and regulatory activities for medical device companies.
This cloud-based solution for medical device customers has built-in industry best practices that are developed by industry experts with experience in medical product development. A cloud-based solution has the advantage and ability to preconfigure, reducing entry obstacles, cost and time to implement PLM in the cloud for medical device companies. Moreover, validation support is available within the industry software and computer software assurance with other significant upgrades. As this solution evolves and best practices develop further, it continues to offer rapid improvement to the industry.
Managing design data
The PLM cloud-based solution focuses on design data management, product line management, and quality process management.
Managing the design data allows you to:
- Monitor the status and performance of your team and their deliverables.
- Maintain data synchronized across domains.
- Connect the design to the quality process with a multi BOM providing multi-domain data management and CAD software.
- Leverage the system of record to organize it by matching the medical device, product lines, SKU structures and bottom management.
- Map requirements and perform design track work to coordinate efficiency across the organization and connect that history to the design history.
There are also new risk management capabilities: ISO 14971, for example, is a standard for the industry that addresses hazard analysis and connects to the requirements and testing for design trace. Also, there is a structured way to manage labeling content into various labeling tools, coordinating the UDI information into the product line and SKU management and the data consumption into the labeling.
Kappa is another essential process that appears first in an audit, tying into the data structure of a device. A QMS system may address it from a paper documentation standpoint, implementing Kappa into the change control process, data revisions, investigations, and the data workflow synchronizing these activities.
Finally, the preconfigured cloud advantage provides IQ and OQ documentation during deployment to customers, providing improved time and value. So, PLM goes beyond engineering, encompassing business processes and collaborating with product development, quality organization, regulatory organization, and marketing organizations.
Learn more in the podcast.
Siemens Xcelerator, the comprehensive and integrated portfolio of software and services from Siemens Digital Industries Software, helps companies of all sizes create and leverage a comprehensive digital twin that provides organizations with new insights, opportunities and levels of automation to drive innovation.
For more information on Siemens Digital Industries Software products and services, visit siemens.com/software or follow us on LinkedIn, Twitter, Facebook and Instagram. Siemens Digital Industries Software – where today meets tomorrow.
