Our Service

• Process definitopn and optimization
• Preparation for external and internal audit (also for FDA)
• Preparation and implementation for internal audit
• Production documentation
• Process documentation
• Approval of medical devices according to CE and FDA
• Risc Analysis and Management according to ISO 14971
• Software documentation (according to IEC 62304)
• Usability according to IEC62366
• Safety of medical devices according to IEC 60601-1 Icl. electric security
• EMC compatility