India’s Sahajanand Medical Technologies addresses compliance challenges by digitalizing traceability, auditability, and coordination across engineering, quality, and regulatory workflows

Sahajanand Medical Technologies, a cardiovascular medical device manufacturer based in India, has been scaling its international operations while attempting to manage increasingly complex product development and regulatory requirements.

As its portfolio expanded, the organization faced fragmentation across engineering, quality, and program management data, limiting traceability and slowing compliance workflows tied to global standards such as US FDA 21 CFR Part 820 and ISO 13485.

The firm’s legacy approach had relied on partially digitized systems and manual coordination between teams, which created inconsistencies in design documentation, change tracking, and verification processes. This made it difficult to maintain a continuous record from initial requirements through manufacturing and post-market updates—an essential capability in regulated medical device environments.

To address these issues, the organisation announced it has implemented a centralized product lifecycle management environment to unify data and processes across functions. The transformation focuses on establishing a continuous digital thread linking development, quality, and regulatory workflows. Key elements of the implementation include:

  • A single source of truth for engineering, quality, and program data
  • End-to-end traceability from requirements through design, manufacturing, and validation
  • Structured management of design history files and device master records
  • Integrated change management workflows with auditability
  • Program planning and schedule coordination across cross-functional teams
  • Digitized test, verification, and risk analysis processes aligned with compliance requirements

The firm’s Chief Information Officer, Girish Kewalramani, said the initiative created “a data backbone… connecting engineering and quality teams” and improving “visibility across product development,” adding that a more unified approach supports “rigorous compliance requirements… while bringing… technologies to market more efficiently.”