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Compliance

At Atos Medical we take seriously our responsibilities to act ethically and in compliance with the laws and regulations in the countries in which we operate. We believe that being compliant makes us a better company in providing products and services for patients and Healthcare Professionals.

Atos Medical is certified according to:

  • Medical Device Directive MDD 93/42/EEC
  • SS-EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes
  • Canadian Medical Devices Conformity Assessment System (CMDCAS)

Atos Medical has a certified quality system and our procedures follow all relevant laws, regulations and applicable guidelines in the USA, Canada and Asia-Pacific as well as in Europe and all other markets in which we are represented.

For subsidiaries and distributors only: Copies of our certificates can be downloaded via our Extranet. Click at “ExtraNet” in the top left corner to access our ExtraNet.

 

Contact compliance:

Email: Marie.Lange@atosmedical.com

Ph: +46 415 19810 / +46 733 019 887

Compliance reporting