The medical device sector has many challenges for manufacturers or suppliers, in Europe under Regulation (EU) 2017/745 (MDR) in the USA or in Switzerland under the MedDO.
Our experts at Axxos will help you to successfully maneuver through the requirements with clever registration strategies or find tailor-made solutions for your situation.

Whether it’s the technical documentation for CE marking in Europe, the approval of your device in Switzerland or the development and efficient introduction of a practical quality management system – Axxos will support you in all challenges.
This creates additional organizational value.

EU- and CH-REP
MDR Technical Documentation
Clinical evaluation of medical devices
Post-market surveillance
Risk Management
Gap analysis and internal status audits
Quality Management Services
Update service standards and regulations
Swissmedic inspections