Paramed

Quality

 

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

 

http://www.imq.it/it/index.html

 

All our products are FDA cleared 

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

 

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