PLM for medical devices covers the need of all teams involved in the whole product life cycle, from the device design development to the production and finally to regulatory submission.

 

In this fourth podcast in the Teamcenter X solution series, we discover the impact of cloud and PLM on small and medium-sized businesses. Alexandre Berthod, Global Marketing Manager at Siemens Digital Industries Software, and Ryan Bauer, Director of Medical Device & Pharmaceutical Solutions at Siemens, discuss the challenges of developing new medical devices and the following advantages of PLM cloud solutions.

 

This solution is built on the Siemens Teamcenter platform for enterprise-grade product lifecycle management and preconfigured to support core product development, quality, and regulatory activities for medical device companies.

 

Cloud solutions offer real benefits, focusing on core areas at a high level, including design, data management, product line management, and quality process management.

 

This episode includes some of the following key points:

• Monitors the status and performance of your team and their deliverables through multi-domain data management.
• Provides product line management to leverage the system of record to organize and match the medical device, product lines, and all the SKU structures. Also, BOM management assists to organize it for design transfer and communications with regulatory authorities.
• Delivers quality process management to provide advanced capabilities built into map requirements and perform design tracing to provide a framework for risk and change control, coordinating efficiency across an organization, connecting to the design history file in a database manner.
• Provides integrated risk management according to ISO 14971, a standard for the industry to handle hazard analysis and connection into requirements and testing for design trace.
• Delivers a structured way of managing your labeling content into different labeling tools and coordinating UDI information into the product line, SKU management, and data consumption into the labeling.
• Provides validation support on the cloud, having it available for preconfigured help to offer some IQ and OQ documentation during the deployment to speed customers’ time to value.

Connect with Alexandre Berthod:

• LinkedIn

 

Connect with Ryan Bauer:

• LinkedIn

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