Elekta ENOVIA Case Study: Regulatory Compliance in Medical Device PLM

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Elekta ENOVIA Case Study: Regulatory Compliance in Medical Device PLM

Case study showing how Elekta uses ENOVIA to manage product data, ensure FDA compliance, and enable instant audit access across global teams.

Published

June 4, 2026

Read time

3 min read

Source

Elekta, a leader in radiation therapy systems, replaced paper-based processes with ENOVIA to consolidate engineering data, BOMs, and workflows. The platform supports 2,500 users across design centers in Sweden, the UK, and China, providing a single source of truth for product lifecycle information. This enables rapid document retrieval during regulatory audits and supports collaboration with partners and future ERP integration.

Key takeaways

ENOVIA replaced paper systems to meet FDA and international regulatory requirements for medical devices

Single digital repository provides immediate access to all product and process documentation during audits

Global teams in three countries use Engineering Central for BOM management and change control

FDA audit praised Elekta for excellent information control and transparency

Planned V6 upgrade targets faster performance and deeper ERP integration

Market overview

SCR methodology note

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