Quality Management

TomTec has established and applies a quality management system for research, design, development, production, distribution, installation and service of medical workstations and medical software for diagnostic image- and information-processing as well as image management systems.

Our Quality Management system has been approved and certified to comply with the requirements of EN ISO 9001:2000 and EN ISO 13485:2003 as well as EN ISO 13485:2003 CMDR.

TomTec as a recognized medical industry partner considers it essential to comply with international quality system regulations, such as required in EU Directive 93/42/EEC including 2007/47 EC and US Quality System Regulation 21 CFR §820 (GMP).

TomTec's Senior Management is enforcing the QM system throughout the company. Our main goal is continuous improvement of the companies effectiveness and efficiency as well as
of our product quality.