After my Study of Physics I started my carreer in the plastics industry. Positions like Quality Director, Senior Production Manager, technical Sales Manager in a world wide acting enviroment as an employee in different companies complete the picture.I ventured into independence with the maintanance of Quality Management Systems and external project management.Today I work solely as a consultant for medical devices, maintanance of Quality Management Systems, approval of medical devices, Training and consulting,Lecturer for international Regulatory AffairsDue to a long engagement and private affairs I moved now to Zürich, Switzerland. I am start to run now Martin Hempel Consuling GmbH, located in Zürich to avaoid any problems with allowences with the swiss law.You can reach me now also under mhempel@mh-c.ch.The company Sigma Tools Limited is closed.Working Areas: Consulting, project management, qualitäty management, medical Devices, audit/inspection training & preparation, gap analysis, ISO 9000, ISO 13485,QSR, MHLW documentation, MPG, MDD 93/42/EEG, CE assesment of conformity, OEM, private label, regulatory affairs FDA, PAL, CMDCAS, ANVISA, Reprocessing of medical devices, MRI safety of passive implants, Biocompatibility of medical devices, international experience and social competence