Quality

With a focus on patient safety, customer satisfaction and business development ABIGO Medical develops, produces and markets products with reliability and quality. We comply with all laws and regulations that apply to the safety and efficacy of our products and the standards that are relevant to our processes in the markets we operate.

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

  • EU Medical Device Regulation (MDR) 2017/745
  • EU Medical Device Directive, 93/42/EEC
  • Quality standard EN ISO 13485:2016
  • Environmental standard EN ISO 14001:2015
  • We also have an MDSAP certificate that allows market access in the US, Australia, Canada, Japan and Brazil