• BIOPTRON AG in-house laboratories are constantly engaged in testing and optimizing BIOPTRON devices according to the latest scientific studies carried out by independent institutions. Simultaneously, BIOPTRON devices are further certified by accredited independent testing institutes. Our business processes, including R&D, supplier evaluation, the supply of components to production, ongoing inspections and the product itself, fulfill all expected regulations according to the European Community medical device directive 93/427 EEC, as well as particular national regulations of the local markets.

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  • DEKRA ISO certificate for Quality Management System: EN ISO 13485:2012 + AC:2012, issued in 19.07.2016

  • DEKRA EC certificate for the Quality Assurance System according to the Medical Device directive 93/42/EEC, annex II excluding section (4), issued in 19.07.2016.

  • DEKRA is an accredited notified body with ID 0124

  • Gold Medal,
    China Association
    of Inventions,
    Foshan, 2018

  • Gold Medal,
    Invent Arena,
    Trinec, 2018

  • Gold Medal,
    International Federation
    of Inventors’ Association,
    Geneva, 2018

  • Gold Plaque and
    Gold Medal,
    Belgrade, 2018

  • WIPO Medal
    for inventors,
    Belgrade, 2018