Case Study
Transferring a Legacy Line with Confidence
A leading medical device manufacturer needed to transfer an existing production line for a single-use urological diagnostic device from the U.S. to a strategic European site. The goal was to centralize operations, streamline logistics, and maintain uninterrupted manufacturing during the transition. With roughly 150 pieces of equipment, outdated documentation, and evolving product specifications, the project was high-stakes and complex.
Overview
Ascential was selected as the partner of choice based on its proven success with line transfers, ability to manage CE compliance, and reputation for acting as a seamless extension of the client’s internal team.
Challenge
The client had unique and complex needs. The project involved 32 separate pieces of equipment and fixtures, many of which required CE marking before they could be commissioned in the new facility. Complicating matters, the receiving site had limited familiarity with the equipment and documentation was outdated, incomplete, or inaccurate. In several cases, the original part drawings didn’t match the physical product, leading to mid-project redesigns and rapid turnaround needs.
Solution
Ascential took full ownership of the project as an end-to-end partner. Ascential’s team established the process from the ground up, initiating weekly customer touchpoints, organizing a full engineering Q&A tracker, and managing documentation in alignment with the client’s internal systems.
Key aspects of the solution included:
- Comprehensive project planning and weekly status reports for control and transparency.
- CE marking support across all qualifying systems, including risk assessments and documentation packages.
- Redesign and build of custom fixtures after legacy part drawings proved obsolete.
- Live FAT demonstrations and in-person operator training in Ascential’s facility to shorten the learning curve and ensure successful ramp-up at the receiving site.
~150
components, fixtures, and systems transferred
Successfully managed a high-volume, multi-part transfer across 32 unique build packages, each with its own scope and technical requirements.
Results
While there were no official acceleration metrics provided by the client, Ascential’s coordination and technical agility kept the project on track, even amid major changes in scope. By handling procurement, validation, training, and delivery under a single roof, Ascential was able to absorb last-minute engineering changes and equipment shifts without missing key milestones.
Conclusion
Transfers of legacy medical manufacturing lines are never simple. But with the right partner, they don’t have to be risky. Ascential delivered the flexibility, engineering expertise, and global coordination this project required, transforming a fragmented scope of work into a high-quality, repeatable process. The result was the smooth transfer of a complex product line into the EU, with zero disruption in operations.
Key Highlights
Full CE compliance for all qualifying systems
Delivered risk assessments and documentation for machinery requiring CE marking, ensuring a smooth regulatory path for the receiving EU facility.
End-to-end ownership under one project schedule
Eliminated vendor fragmentation by handling design clarification, fabrication, validation, FAT, and training—all through a single integrated partner.
Critical FAT testing completed on time
Ascential delivered in-person FAT ahead of a hard client deadline, enabling a smooth handoff before key personnel transitioned.