Paramed is highly committed in quality continuous improvement which result is testified by the maintained international volunteer certifications


UNI EN ISO 13485:2012

UNI EN ISO 9001:2008


These quality system certifications are intended to support the presumption of conformity towards the European Directive 93/42/EEC on Medical devices.


Paramed markets its products within EC marketplace according to Annex II, VI or IV procedures of the 93/42/EEC directive. Our medical devices are classified as Class IIa and the Notified body releasing the CE mark is IMQ S.p.A. (CE0051


All our products are FDA cleared


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