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Quality System Audits | Medical Device | IVD Equipment | CE Mark | QMS Activities | FDA... - 0 views

www.arazygroup.com/QualitySystemAudits

quality system audits medical device IVD equipments CE mark QMS activities FDA Taiwan regulation health Canada CMDCAS service professional ISO1348

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.
arazy-group

Italian NSIS Repertorio Registration | Medical Devices | CE Marked | National Regulatio... - 0 views

www.arazygroup.com/NSISRepertorio

Italian NSIS repertorio registration medical devices CE marked national regulation device FDA consulting listing and diagnostic industry clinical trial data management

shared by arazy-group on 29 Jul 11 - No Cached
  • arazy-group on 29 Jul 11
     
    Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.
  • arazy-group on 22 Sep 11
     
    Medical devices of all classes, active implantable devices and procedure packs and kits sold in Italy to the Public Sector must be registered in an Italian database ("Repertorio"), administered by the Ministry of Health through its new system, NSIS.
arazy-group

Europe Union | Medical Devices |IVD Devices | IVD| CE Mark Registration | Active Implan... - 0 views

www.arazygroup.com/europeanunion

Europe union medical devices IVD mark registration active implant design dossier preparation ISO 13485 eu authorized representative service ce marking markings FDA 510k

shared by arazy-group on 22 Sep 11 - No Cached
  • arazy-group on 22 Sep 11
     
    Medical devices are divided into class I, IIa, IIb and III. IVDs are divided into four categories: General IVDs, self-diagnostics, list A and list B. All medical devices exempt class I and General IVDs require the involvement of a Notified Body and the implementation of a quality management system, usually in line with ISO 13485.
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