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Integration of Product Lifecycle Management in Cardiovascular Device Manufacturing
Sahajanand Medical Technologies deploys Siemens digital thread software for connected development.
www.siemens.com
Sahajanand Medical Technologies (SMT) has implemented product lifecycle management (PLM) software from Siemens Digital Industries Software to establish a centralized digital infrastructure connecting engineering, quality, and regulatory workflows.
Strategic Objectives and Industry Context
Medical device production requires strict compliance with international standards such as US FDA 21 CFR Part 820 and ISO 13485. SMT, a manufacturer of cardiovascular devices, faced the operational challenge of managing complex engineering, quality, and program data across expanding global operations. The collaboration addresses the need for centralized data visibility, end-to-end traceability, and standardized documentation across cross-functional teams.
Technical Solution and Implementation Roles
Siemens supplied its Teamcenter platform from the Siemens Xcelerator portfolio to serve as a unified data backbone. System deployment, configuration, and user onboarding services were executed by Siemens implementation partner ThinkInnov Solutions.
Responsibilities are distributed across three primary roles:
- Siemens provides the PLM platform and domain-specific software functionality.
- ThinkInnov Solutions manages technical execution, system integration, and user training.
- SMT operates the platform within its research, development, and quality divisions.
The architecture integrates program planning, classification, and schedule management. Specialized medical device features automate the creation and maintenance of design history files (DHF) and device master records (DMR). The software also handles change execution, risk analysis, and test verification processes to maintain data consistency from initial requirements to product release.
System Integration and Operational Use Cases
The software connects previously siloed teams within a single digital environment. Engineering, quality, and program management data are linked to establish traceability across the entire lifecycle.
Target use cases include:
System Integration and Operational Use Cases
The software connects previously siloed teams within a single digital environment. Engineering, quality, and program management data are linked to establish traceability across the entire lifecycle.
Target use cases include:
- Generating DHF and DMR documentation automatically within regulatory frameworks.
- Tracking engineering changes and test results against initial design requirements.
- Standardizing risk analysis workflows during product development.
Measured Impact and Operational Benefits
The deployment eliminates fragmented data structures by providing a single source of truth across research and development and quality departments. Structuring workflows within a connected PLM framework enhances process stability, simplifies audit preparation, and accelerates new product development timelines for cardiovascular technologies.
"With Teamcenter, we are establishing a data backbone that helps connect our engineering and quality teams while improving visibility across product development processes," said Girish Kewalramani, chief information officer, Sahajanand Medical Technologies Ltd. "As we continue to grow internationally, having a more connected approach to managing product information will help us support the rigorous compliance requirements of the medical device industry while bringing innovative cardiovascular technologies to market more efficiently."
Edited by Evgeny Churilov, Induportals Media - Adapted by AI.
www.siemens.com
The deployment eliminates fragmented data structures by providing a single source of truth across research and development and quality departments. Structuring workflows within a connected PLM framework enhances process stability, simplifies audit preparation, and accelerates new product development timelines for cardiovascular technologies.
"With Teamcenter, we are establishing a data backbone that helps connect our engineering and quality teams while improving visibility across product development processes," said Girish Kewalramani, chief information officer, Sahajanand Medical Technologies Ltd. "As we continue to grow internationally, having a more connected approach to managing product information will help us support the rigorous compliance requirements of the medical device industry while bringing innovative cardiovascular technologies to market more efficiently."
Edited by Evgeny Churilov, Induportals Media - Adapted by AI.
www.siemens.com
