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CERTIFICATION BIOPTRON-AG in-house laboratories are constantly engaged in testing and BIOPTRON devices are evaluated based on scientific studies carried out by independent institutions. Also, BIOPTRON devices are further certified by accredited independent testing institutes according to the following rigerous criteria - Research and Development, supplier evaluation, supply of components to production, on going inspections and the functioning of the products which fulfill all regulations according to the European Community Medical Directive 93/42/EEC as well as for specific country and international regulations. CERTIFICATES DEKRA ISO Certificate for Quality Management System EN ISO 9001:2008 DEKRA ISO Certificate for Quality Management System EN ISO 13485: 2012 + AC: 2012 DEKRA ISO Certificate for Quality Management System ISO 13485-2003-CMDCAS DEKRA ISO Certificate for the Quality Assurance System, Medical Device directive 93/42/EEC , annex II excludig section (4) 510(K) Clearance, for further information visit "510(k) Premarket Notification Database" http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm The BIOPTRON 510(k) Number is K032216 For BIOPTRON AG Company DEKRA ISO Certificate for Quality Management System: ISO 9001:2008 and EN ISO 13485:2012 + AC:2012: issued in 2016 and ISO 13485-2003-CMDCAS, certified since 24.09.2013 DEKRA EC Certificate for the Quality Assurance System according to the Medical Device directive 93/42/EEC, annex II excluding Section (4), issued on 19.07.2016. DEKRA is an accredited notified boy with ID 0124
BIOPTRON AG PHOTOTHERAPY PRODUCTS & EQUIPMENT
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