LEPINE, a French manufacturer of orthopedic implants, has chosen the Ellistat Quality Suite
LEPINE is a family-owned company founded in Genay (69) more than 300 years ago. Specializing in the manufacture of orthopedic implants and related instruments, it now has three production sites in France, as well as about ten international distribution subsidiaries. In 2024, it generated revenue of €76 million with a workforce of 500 employees and managed 5,000 product SKUs per year. In 2025, the company decided to invest in a digital solution to manage all of its quality controls and selected the ELLISTAT Quality Suite.
LEPINE was originally a cutlery company based in Lyon, founded by Philippe Martin de Lespinaz. She then began specializing in surgical instruments in 1860. Acquired in 1988 by Patrick Pfaifer, the company then refocused its operations on the manufacture and sale of orthopedic prostheses (knee, hip, shoulder, and extremities). Today, the company is run by his two sons, Valentin and Rodolphe Pfaifer.
LEPINE’s strength lies in its comprehensive industrial expertise, with a fully in-house manufacturing process: casting, forging, machining, coating, ceramics, plastics processing, and shape-memory alloys. Only sterilization is outsourced. The company is ISO 13485 certified, and its testing laboratory, «LEPINE LAB,» is ISO/IEC 17025 accredited (AFNOR Cofrac).
From Paper to a Digital Solution
In 2023, the company decided to move away from paper-based processes and digitize all of its quality control procedures—from the receipt of raw materials through final inspections, including the receipt of sterilized products.
Among the software solutions available on the market, LEPINE quickly chose ELLISTAT. Laurence Fiscus, Director of Quality, comments : «We attended demonstrations of the Quality Suite developed by the French company ELLISTAT. Right from the start, we were impressed by their seamless and intuitive solution, which was perfectly suited to our needs.”. "
In late 2025, the company made an investment, and implementation of the first modules—SPC and IQC—began at three sites in France. The module SPC (Statistical Process Control) allows you to view all production data, monitor statistical trends in processes, and control production in real time. The module IQC (Incoming Quality Control) automates and reduces inspections.
Using the ELLISTAT Quality Suite
Within LEPINE, the Ellistat Quality Suite covers several key stages. Upon receipt, it allows users to verify the compliance of raw materials and components, record inspection results (dimensional, visual, and documentary), and facilitate decision-making regarding acceptance, rejection, or exceptions.
During production, the solution tracks critical characteristics, monitors process deviations (SPC, control charts), and provides real-time decision support through alerts when tolerance limits are exceeded.
For the final inspection, it verifies that the finished product meets specifications before release, records the results, and serves as the basis for batch release.
The implementation project will span two years, with the goal of digitizing all production sites. The measuring instruments will be directly connected to minimize data entry errors, secure the data, and maintain a complete history. A new ERP system will also be integrated with ELLISTAT via an API.
The Benefits of the Quality Suite
Among the key benefits of the Ellistat Quality Suite, Laurence Fiscus highlights data reliability and security (reduced data entry errors, standardized and secure data, elimination of paper, and reduced risk of data loss). The solution also offers full traceability (history of all inspections, quick access to data in the event of an audit, direct links to batches, products, and suppliers). It also enables a time savings and increased efficiency thanks to guided and automated data entry, automatic calculations—tolerances, capability, SPC—and rapid report generation.
The solution allows you to manage the process with real-time monitoring of deviations, alerts in the event of non-compliance, and decision support (acceptance or rejection). Statistical data analysis, the identification of trends and causes of deviations, as well as process optimization and waste reduction, contribute to a strategy of’continuous improvement.
When it comes to regulatory compliance and audit support, the Quality Suite meets the requirements of the ISO 13485 / MDR standard. Records are easily accessible and usable, and evidence is immediately available.
" This decision to go digital is revolutionizing the company, says Laurence Fiscus. «It involves gathering and »customizing» data, as well as providing support to the teams, even though ELLISTAT's modules are fully integrated and easy to use. However, this major change has been very well received internally overall."