Case Study: Siemens Healthineers achieves GHS compliance and uninterrupted US/EU market access with Sphera

Siemens Meets Major GHS Compliance Requirement to Ensure Access to US/EU Markets, Gain Competitive Edge

Siemens Healthineers faced a major regulatory challenge when U.S. OSHA and EU GHS changes required reclassification of thousands of reagents by the June 1, 2015 deadline to maintain market access. To meet this high‑visibility mandate and train product stewardship teams, Siemens Healthineers partnered with Sphera, leveraging Sphera Intelligent Authoring along with managed regulatory content and product compliance services to drive the global GHS implementation.

Sphera delivered SDS authoring, regulatory content, training and product compliance analysis that let Siemens Healthineers reassess roughly 3,500 reagents, update some 70,000 Safety Data Sheets and produce GHS‑compliant labeling in 20 languages (and coordinated changes to tens of thousands of label files) before the deadline. The Sphera solution avoided product interruptions in key markets, sped responses to customer inquiries by enabling quick searches for substances of concern, and helped Siemens Healthineers meet compliance while advancing its safer‑product goals.

Siemens Healthineers

Maureen Gillis

Senior Manager, EHS