Case Study: OSSTEM IMPLANT achieves faster, fully compliant medical-device delivery with Dassault Systèmes 3DEXPERIENCE

OSSTEM IMPLANT - Customer Case Study

OSSTEM IMPLANT, a leading Korean dental medical device manufacturer and global implant producer, faced growing regulatory pressure and the need to automate Unique Device Identification (UDI) and related business processes so it could scale customization and win global market share. To meet this challenge the company turned to Dassault Systemes, adopting the 3DEXPERIENCE platform and its License to Cure for Medical Device industry solution experience to unify product development, quality and regulatory workflows.

Dassault Systemes implemented an integrated 3DEXPERIENCE solution that links design, BOM/DMR, certification documents, UDI generation and FDA GUDID (HL7 SPL) submission into a single source of truth. The result: eliminated disconnected processes, faster and more accurate UDI generation and submission, improved product quality control (now allowing DI and PI tracking via UDI), timelier responses to quality issues, and better compliance with international regulations—helping OSSTEM IMPLANT accelerate innovation and reduce time to market.

OSSTEM IMPLANT

Kim Tae-yong

Head of The Information System Management Team