Case Study
Automating ROHS 3 Compliance for a MedTech Manufacturer
Solution
PLM | Compliance | Automation
Industry
Manufacturing | MedTech | Healthcare | Life Sciences
Core Technology
Oracle Agile PLM
Overview
When new EU hazardous substance regulations threatened production and compliance, Xavor helped a Medtech leader turned manual oversight into automated governance. By embedding smart checks directly into their Agile PLM solutions, we ensured seamless adherence to ROHS 3, turning a regulatory challenge into a competitive advantage.
Business Challenge
Facing a stringent update to the EU’s Regulation of Hazardous Substances (ROHS 3), our client, a leading medtech manufacturing company, needed to audit and remove all non-compliant materials from production before the deadline. Their existing process, managed manually by a small team of Change Analysts, was overwhelmed by the volume of parts. This manual review was slow, inefficient, and highly prone to human error, creating significant risk of non-compliance and production disruption.
the solution
The client’s Document Control team partnered with Xavor to embed compliance directly into their workflow. Our PLM experts developed an automated process extension within the company’s existing Agile PLM system.
The solution used a custom script (written in Script PX) to automatically flag and block any part with only ROHS 2 clearance from being released into production. The automation was first deployed in a development environment for testing. We also trained the client’s in-house team to edit and adapt the script for future regulatory changes, ensuring long-term self-sufficiency.
“I reached out to Xavor and asked if there was some way we could add some kind of automation to our path… Honestly, without me having even to clarify very much, pretty much the perfect automation was set up for us in our dev system.”
— Document Control Manager
outcomes & benefits
Eliminated compliance errors:
Automated enforcement ensured only ROHS 3-compliant parts could be used, removing human error from the critical review step.
Ensured timely compliance:
The company seamlessly met the ROHS 3 deadline with zero disruption to ongoing production schedules.
Unlocked team capacity:
The Change Analysts were freed from manually screening thousands of parts, allowing them to focus on higher-value tasks.
Built future agility:
The easy-to-edit script provides a durable framework that can be quickly adapted for future regulatory changes.
“We had an issue where our team was challenged by the new ROHS 3 regulation, which strictly controls what chemicals can be shipped into the EU. This solution turned a major compliance hurdle into a managed process.”
— Document Control Manager
Tools & tech stack
conclusion
Xavor’s solution exemplifies how deep PLM knowledge and strategic automation can turn compliance from a cost center into a competitive asset. We partner with clients not just to solve immediate problems, but to build durable, intelligent systems. This project delivered immediate ROHS 3 compliance while establishing a scalable, self-sufficient foundation for the future—showcasing our commitment to creating lasting operational value and resilience for Medtech leaders.
Still reviewing compliance manually in Agile PLM?
Xavor delivers Agile PLM automation your team can edit for future regulations.