Case Study: LifeWatch achieves global collaboration and FDA traceability with Polarion Software

LifeWatch - Customer Case Study

LifeWatch, a multinational medical device company with over 500 employees, faced two key challenges: coordinating project teams spread across multiple countries and time zones, and maintaining traceable, regulation-ready requirements and documentation that had been kept in traditional Office files—making FDA and other compliance processes slow and inefficient.

LifeWatch adopted Polarion’s web-based ALM to centralize project information, import existing Office documents, and create linked artifacts for end-to-end traceability. The rollout reached full team operation in 4–6 months (scaling from 1 to ~20 users), improved global collaboration and visibility, lowered training costs, and provided a solid documentation foundation for FDA 510(k) submissions—enabling the company to use Polarion for future large-scale projects.

LifeWatch

Rafi Heumann

COO