Case Study: Amplitude achieves streamlined, compliant quality management with MasterControl eQMS

Digitalizing a Quality Management System Rolling Out the MasterControl eQMS

Amplitude, founded in Valence in 1997, is a 400+ employee medical‑device company selling orthopedic products in over 30 countries. Rapid international growth and evolving regulations (MDR, ISO 13485:2016, FDA CFR 21, ANVISA) forced Amplitude to modernize its Quality Management System to ensure compliance, speed time‑to‑market and support certification objectives like MDSAP.

Working with Apsalys, Amplitude rolled out MasterControl’s eQMS across nine modules (documents, training, complaints, deviations, CAPA, change control, SCAR, audits, suppliers) in a phased 2015–2018 program that included planning, configuration, validation and training. The implementation now supports 300+ users and 900+ documents, helped secure four certifications (ISO 13485, ANVISA, CMDCAS, MDSAP), enabled 3,200 workflow collaborations and 1,545 incident resolutions, and delivered streamlined processes, full traceability, stronger data security and real‑time visibility for faster, data‑driven decisions.

Amplitude

Vianney Lharminez

Quality System Manager