ISO 13485:2012 Certified

BEMER International AG is DIN EN ISO 13485:2012 certified.

(DIN is the German Institute for Standardization, a member of the International Organisation for Standardization ISO)

This standard deals with the requirements for quality management systems for the manufacturers of medical devices. An established and certified quality management system supports compliance with the relevant European CE directive for medical devices.

Certification confirms the following conditions are complied with:

The standard must be implemented within the entire organization. All applicable requirements of a medical device must be fully complied with.

Extensive quality control including suppliers must be ensured.
For assembly, inspection, shipping, and service, proven and thus optimized processes are to be used.

Only trained and verifiably qualified personnel may be employed.
BEMER has always set the highest standards regarding the excellent quality of its products and work processes and this is also confirmed by this certification. It goes without saying that we will not only maintain this level but ‒ as far as possible ‒ even improve on it for us and for our customers.

This statement can be viewed on, from where it has been sourced.

ISO DIN EN ISO 13485:2012 – detailed explanation by

SA Department of Health

CE Marking

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