Quality

With focus on patient safety, customer satisfaction and business development ABIGO Medical will continue to develop, produce and market products with reliability and quality. We comply with all laws and regulations applicable to our products’ safety and effectiveness and the standards that are relevant to our processes.

 

ABIGO Medical AB is working in accordance with the following regulations and standards:

  • EU Medical Device Directive, 93/42/EEC
  • Quality System QSR (Quality System Regulations) for medical devices in the U.S.
  • Quality standards ISO 9001 and ISO 13485
  • Environmental standard ISO 14001