Measureable success
"In medical fields secured processes and a excellent quality management system are extremely important. Spantec deals intensely with quality standards in the area of medicine and healthcare. Our quality management system offers our customers safety and an added value and allows us to measure the success of our projects. Other Companies should benefit from our experience; therefore we assist in implementing and maintaining quality standards."
Dipl.-Ing. (FH) Stefanie Mastny, BSc - Head of QM, Spantec GmbH
Certificate
QM - Quality Management
Spantec intensively works with quality standards and processes and is EN ISO 13485:2003+AC:2007+AC:2009 certified itself. Benefit from our experience in order to help you with the implementation of necessary quality standards.
Next to consulting we also do risk analysis and risk management for your Hard- and Software products in order to get your products fit for the market.
Risk analysis
We conduct risk analysis and risk assessments for your hard- and software products following the guidelines of EN ISO 14971:2007 and support you with the implementation of those guidelines and rules.
For this purpose our risk management team analyzes your products and assesses the risks of your product.
Benefit from an experienced team with a background from medical device development and risk management.
