Sahajanand Medical Technologies has deployed Siemens’ Teamcenter product lifecycle management software to connect its medical device development, quality and regulatory processes.
The cardiovascular device manufacturer will use the platform as a digital thread backbone linking engineering, quality and programme-management data across its operations.
The deployment forms part of Sahajanand Medical Technologies’ wider digital transformation strategy as the company expands its international presence and develops cardiovascular products for global healthcare markets.
By centralising product information, the company aims to improve collaboration between teams, streamline new product development and support compliance with international medical device standards.
The platform will support requirements under the US Food and Drug Administration’s 21 CFR Part 820 quality system regulation and the ISO 13485 quality-management standard for medical devices.
“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 at Sahajanand Medical Technologies.
“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.”
Sahajanand Medical Technologies is using Teamcenter for collaboration, product classification, programme planning and schedule management.
The deployment also includes medical device-specific capabilities supporting design history files, device master records, change management, and testing and verification processes.
The system is intended to provide end-to-end traceability from initial requirements and product design through manufacturing and quality activities.
“Medical device manufacturers are balancing increasing product complexity with demanding regulatory requirements,” said Mathew Thomas, Vice President and Managing Director for India at Siemens Digital Industries Software.
“By connecting product development and quality processes, Teamcenter helps provide the visibility, traceability and collaboration needed to support compliance while helping bring innovative products to market faster.”
Siemens implementation partner ThinkInnov Solutions delivered the deployment, configuration and user-onboarding services.
The implementation establishes a unified product lifecycle management environment across Sahajanand Medical Technologies’ research and development and quality teams, covering processes from initial requirements and risk analysis through product release and change execution.