Learn how Teamcenter X provides the benefits of cloud-based solutions for medical devices, including design, data management, product line management, and quality process management.
Alexandre Berthod, Global Marketing Manager at Siemens Digital Industries Software, interviews Ryan Bauer, Director of Medical Device & Pharmaceutical Solutions at Siemens, discussing the challenges of developing new medical devices and the benefits of PLM cloud solutions built on the Teamcenter platform.
This summary blog examines the fourth session in the PLM Teamcenter X series, discussing the impact of cloud and PLM on small and medium-sized businesses. Siemens has a significant portfolio of software that perfectly matches the current needs of the medical industry.
PLM for medical devices is built on the Siemens Teamcenter platform for enterprise-grade product lifecycle management, preconfigured to support core product development, quality, and regulatory activities for medical device companies.
It’s a cloud-based solution for medical device customers with built-in industry best practices. This solution is developed with industry experts and real experience in medical product development. One of the advantages of being cloud-based is the ability to preconfigure it, reducing any entry obstacles and reducing the cost and time to implement PLM on the cloud for medical device companies. Also, crucial validation support is available within the industry software and computer software assurance, along with other significant upgrades. Therefore, as the solution evolves and best practices develop further, it can continue to offer that improvement rapidly to the industry.
Manage design data
The solution focuses on three core areas: design data management, product line management and quality process management.
Managing your design data allows you to:
- Monitor the status and performance of your team and their deliverables.
- Keep your data synchronized across domains.
- Connects the design to the quality process with a multi BOM for multi-domain data management and CAD software.
- Leverage the system of record to organize it by matching your 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 new risk management capabilities. For example, according to ISO 14971, a standard for the industry, they handle hazard analysis and connect to the requirements and testing for design trace.
In addition, labeling can be a problem area in the industry – a top reason for recalls. Therefore, there is a structured way to manage labeling content into various labeling tools and then coordinate the UDI information into the product line and SKU management and the data consumption into the labeling.
Kappa is another vital process that appears first in an audit. Kappa ties 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.
Lastly, the advantage of this being on the cloud is having it preconfigured, offering IQ and OQ documentation during deployment to customers, and providing improved time and value.
In conclusion, PLM goes beyond engineering, encompassing business processes and collaborating with many things, including product development, quality organization, regulatory organization, and the marketing organization.
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.
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