Background
Erbe Elektromedizin GmbH from Tübingen is a traditional, globally active medtech company with over 150 years of history. It is one of the pioneers of electrosurgery and today manufactures state-of-the-art systems for various surgical procedures. As a medtech manufacturer, the company is required to comply with the highest regulatory requirements - in particular the EU's MDR and the US FDA. Erbe replaced manual processes with PeakAvenue's “Quality Center” eQMS back in 2012 in order to implement quality assurance efficiently and in compliance with regulations.
Project implementation
The introduction of the eQMS was made possible by a company license, which allows the integration of all relevant quality modules. After training and a test phase, data was transferred from the ERP system and the implementation went smoothly. Today, numerous modules such as FMEA, inspection plan, complaints management, inspection data acquisition and inspection equipment management are in use. Special requirements such as electronic signatures and audit trails were implemented in a user-friendly way. The collaboration with PeakAvenue was always solution-oriented and individually tailored to Erbe's needs - including software adaptations and support for international rollouts.
Result
The introduction of the eQMS has led to measurable increases in efficiency and quality: Inspection processes are simplified, inspection plans can be derived and used efficiently, and inspection equipment is managed in a more targeted manner. Compliance with regulatory requirements such as audit trail and validation has been made much easier. Software updates are now also structured and validated - supported by delta reports from PeakAvenue. The system grows flexibly with the company. A strategic development partnership has been in place since 2024 to further develop the PeakAvenue cloud solution, which is to be fully implemented by 2026.
