Lmb Technologie GmbH has implemented Quality Management Systems that integrate compliance Quality System Regulations and applicable international standards ISO 9001 and ISO 13485 and Medical Device Directive 93/42/EEC.
Quality Management Systems are specifically intended for the Design and development, production, distribution and service of medical devices and systems to produce, handle, treat, store and transport blood and blood components as well as solutions of systems and software for applications in blood banks and industry.
Certificates are issued based on satisfactory audit results that Quality Management Systems are maintained in compliance with ISO 13485 and the Medical Device Directive.
Lmb products are labelled with the CE mark indicating that they are certified to meet the essential requirements of the Medical Device Directive.
Quality Management System (ISO 9001; ISO 13485) and EC Certificates: Certificates